Vantegrate for the Pharmaceutical Industry

AI agents for the pharmaceutical industry: pharmacovigilance, GxP and cold chain without breaking compliance

B2B orders on WhatsApp, adverse events routed to Argus in minutes, recalls within the regulatory deadline, and cold chain alerts on excursion

Big Pharma and biotechGenerics and OTCCROs and clinical trialsDistribution and wholesalersVaccines and medical devices

The hospital pharmacist asks at 7:42 PM, outside business hours, and we lose that month's order: the competitor closed it in fifteen minutes.

A customer reported an adverse event on WhatsApp and we found out four days later by chance: the pharmacovigilance deadline had already passed.

QA transcribes batch records eight hours a day and batch release is delayed 9 days, not because of the analytics but because of paper.

No matter the sub-vertical (Big Pharma, biotech, generics, OTC, vaccines, CROs and clinical research, pharmaceutical distribution, medical devices) or the operating model (direct-to-HCP channel, indirect channel via wholesalers, hospital fulfillment, decentralized clinical trials (DCT), in-house or outsourced CMO/CDMO manufacturing), every manufacturer today runs into the same obstacles:

PV detected lateLow email open rateQA transcribes paperLate thermal excursion

What Vantegrate's AI Platform solves for a Pharmaceutical Industry Company

The suite covers the complete cycle: B2B orders with PV, HCP campaigns, GxP batch records, BI over validated data and last mile with cold chain

From Hospital Pharmacy San Roque's inquiry at 7:42 PM about Ceftriaxone and refrigerated Adalimumab, to case FV-2026-1184 sent to Argus in 11 minutes with an E2B(R3) ICSR and compliance with ANMAT Disposition 5039/2019.

Indirect-channel orders in seconds, PV routed to Argus in minutes, recall executed within the regulatory deadline with documented confirmation, batch records released faster and cold chain monitored at minute zero.

24/7 orders

Indirect channel and conversational PV

WhatsApp 24/7 for B2B orders with lot validation against the ERP and adverse event routing to Argus/Vault Safety in minutes with an E2B(R3) ICSR.

More reads

HCP campaigns and regulatory recall

Communication to the pharmacy network with a Veeva PromoMats template. Recall within the regulatory deadline with documented confirmation.

Faster release

Batch records, CoAs and ICSRs with GAMP 5

IDP for hybrid batch records, CoAs from 80-plus suppliers and ICSRs into E2B(R3) with an ALCOA+ audit trail and GAMP 5 category 4 validation.

Data in seconds

GxP BI and IoT cold chain

OEE/RFT/query rate over WhatsApp without altering ALCOA+; last mile at 2-8°C or ultra-cold -70°C with Sensitech and Controlant live.

INDUSTRY OVERVIEW

What changed in the pharmaceutical industry and why compliance no longer holds up without artificial intelligence

B2B orders with PV in minutes, recall within the regulatory deadline, pre-reviewed batch records and cold chain monitored live

The sector is won by answering the indirect channel 24/7, routing adverse events to Argus in minutes instead of days, executing the regulatory recall within the health authority's deadline with documented confirmation, releasing batch records faster and monitoring cold chain at minute zero, all under ANMAT, FDA 21 CFR Part 11, ICH GxP, GAMP 5 and ALCOA+ integrity.

The patient can't wait

  • The pharmaceutical industry operates under the strictest regulatory framework in the world and, on top of that, under growing competitive pressure.

  • Big Pharma, biotech, generics, OTC, vaccines, CROs, distributors and wholesalers all live with five realities at once: extreme regulation (ANMAT, FDA 21 CFR Part 11, EMA, ANVISA, COFEPRIS, INVIMA, ISP, DIGEMID, ICH Q7-Q10, GxP, GAMP 5, GDP, DSCSA, GS1) where a spec deviation, a biologic temperature excursion or an adverse event not reported in time can jeopardize the manufacturer's license; massive document management for batch records, CoAs, ICSRs, source documents and regulatory dossiers; a fragmented ecosystem of Veeva, Salesforce Life Sciences Cloud, Oracle Argus, MasterControl, TrackWise, Werum PAS-X, LabWare, SAP S/4HANA and TraceLink that all have to interoperate; and an accelerating shift toward decentralized trials (DCT), ultra-cold biologics, and cell and gene therapies.

The inspector doesn't forgive

  • And competition is no longer won on product alone.

  • It is won by answering the indirect channel 24/7, routing the adverse event to Argus in minutes instead of days, reaching the HCP through a channel that actually gets read, releasing the lot faster with a pre-reviewed batch record, and catching the temperature excursion at minute zero, not after the hospital has already rejected the box.

  • All of that without breaking compliance: in pharma, a poorly executed GAMP 5 validation is an inspection observation, and an ICSR filed past deadline is a regulatory sanction.

Del primer WhatsApp al décimo service

Una operación conectada de punta a punta

Before
0Disconnected tools
0Vendors
No visibility
Now
0Platform
0AI agents
Measurable results
INDUSTRY CHALLENGES

5 problems that destroy margin, compliance and regulatory speed in Big Pharma, biotech, generics, CROs and distribution

Five frictions that cost margin, regulatory compliance and operating speed

An indirect channel with no 24/7 coverage, adverse events discovered days late, mass communication to HCPs by mail that almost nobody opens, batch records transcribed by hand by QA, and cold chain with no visibility come up in every conversation with a Head of Commercial, Head of Quality, QP or Head of Pharmacovigilance.

We spoke with dozens of manufacturers, CROs and pharmaceutical distributors before defining our suite. These are the pain points that come up in every conversation with a Head of Commercial, Head of Medical Affairs, Head of Quality, QP, Head of Pharmacovigilance, Head of Clinical Operations or Head of Supply Chain in the sector:

Challenge 01 of 05

Indirect channel with no 24/7 coverage and adverse events detected days late via WhatsApp

We have four reps answering WhatsApp eight hours a day and indirect-channel revenue hasn't moved.

Every time a hospital pharmacist asks about stock outside business hours and nobody answers, we lose that month's order.

Regulatory affairs told us no rep should answer technical questions on WhatsApp, and now we barely answer anything.

Three months ago a customer reported an adverse event on WhatsApp and we found out four days later by chance.

When we relaunch an OTC brand, the commercial team gets swamped with questions the bot doesn't understand and reps can't keep up.

The channel only responds during business hours and it's slow; outside those hours there's no response and the order is lost.

And an adverse event that comes in through WhatsApp can take days to reach pharmacovigilance, against regulatory deadlines measured in hours or a few days (the FDA requires initiating action on a Class I recall within 24 hours, 21 CFR Part 7; expedited PV reports run 15 or 30 days depending on severity).

THE VANTEGRATE PROPOSAL FOR PHARMACEUTICAL

The AI platform for pharma: five agents with native GxP and GAMP 5 compliance

Five coordinated AI agents with native GxP compliance and GAMP 5 validation

Vantegrate covers conversational order taking with PV routing, mass campaigns with Veeva PromoMats templates, regulatory IDP with GAMP 5 and ALCOA+, conversational BI over GxP data without altering integrity, and pharmaceutical last mile with cold chain monitored live, in one integrated implementation.

Without Vantegrate
With Vantegrate

We have reps answering WhatsApp during business hours and the indirect channel isn't moving

Sellium takes B2B orders 24/7 with lot validation and routes PV to Argus in minutes with E2B(R3)

We send thousands of emails to the channel every month and almost nobody opens them

Revio leverages WhatsApp's far higher open rate (sector: 75-98% vs. 20-25%) and executes the recall within the regulatory deadline

QA spends entire days transcribing batch records and release is delayed by paper

Arconte pre-reviews the batch record and speeds up release with GAMP 5 and ALCOA+

We rolled out Power BI years ago and almost no manager uses it

Metrix answers on OEE, RFT and batch yield over WhatsApp without altering ALCOA+ integrity

The datalogger is only read when the truck comes back and the biologic box is already lost

Trazzo catches the temperature excursion at minute zero with Sensitech/Controlant live

That's Vantegrate for pharma:
an integrated suite, implemented turnkey, with baseline metrics agreed with the client, a full GAMP 5 validation package (URS, FS, DS, IQ, OQ, PQ, risk analysis, change control), an immutable ALCOA+ audit trail, and a compliance posture inherited from Salesforce Life Sciences Cloud or Oracle Health Sciences.

Built for global Big Pharma, biotech, generics manufacturers, OTC manufacturers, vaccine producers, CROs and sponsors, pharmaceutical distributors, wholesalers, medical device manufacturers and CMO/CDMO operators across LATAM and the US Hispanic market (Argentina, Mexico, Brazil, Chile, Colombia, Peru, Uruguay, Florida, Texas, California, New York)

Book a discovery session

Here is how each agent works in the pharmaceutical industry, with real scenarios by sub-vertical.

Salesforce
ISV Partner
AppExchange Partner
Salesforce · Since 2009
Oracle
OCI Partner
Marketplace & OCI Partner
Oracle Cloud Infrastructure
SELLIUM FOR PHARMACEUTICAL

B2B order taking on WhatsApp 24/7 with adverse event routing to Argus/Vault Safety in E2B(R3)

WhatsApp 24/7 with lot validation against the ERP and PV routing to Argus in E2B(R3)

Sellium serves hospital pharmacists, wholesalers, KAMs, prescribing physicians and patients in DCT programs 24/7. It validates lots against SAP/Oracle, logs touchpoints in Veeva CRM and routes adverse events to Argus/Vault Safety with a pre-formatted ICSR.

Request a SELLIUM demo

Dato clave

Sellium is the one that takes the hospital pharmacist's order on a Friday at 7:42 PM and routes the adverse event to Argus in minutes.

It lives on the WhatsApp Business API and serves the entire buyer universe in the sector: the hospital pharmacist restocking injectable antibiotics and cold-chain biologics outside business hours, the wholesaler's purchasing manager building the monthly order, the hospital maintenance manager requesting a device by serial number, the KAM coordinating tenders and bid documents, the physician asking for information approved by medical affairs, and the patient in an adherence program with consent.

Critically: Sellium does not promote prescription drugs to the end patient, does not respond off-label, routes adverse events to pharmacovigilance with a pre-formatted ICSR, and relies only on material approved by medical and regulatory affairs.

For pharma, Sellium solves four critical scenarios:

A generics manufacturer with thousands of manual orders from the wholesaler channel moving to a seconds-fast 24/7 response

What practical value you'll find when you open this section

Consider a generics manufacturer whose wholesaler channel today handles thousands of monthly orders by phone and manual WhatsApp with two dedicated reps, response times of tens of minutes and orders lost outside business hours.

With Sellium operating on WhatsApp 24/7, the flow becomes: first response in seconds, most orders closed without human intervention with lot validation against the ERP, no losses from off-hours timing, and the two reps freed up for strategic accounts.

Or a hospital pharmaceutical distributor whose call center handles thousands of daily inquiries, most of them repetitive questions about stock and expiration dates: with Sellium, those inquiries are resolved against the ERP in real time, cold-chain orders trigger alerts to the logistics team, and stock-out complaints drop, freeing up call-center hours and improving the channel experience.

Typical results in Pharmaceutical:

  • More indirect-channel coverage with 24/7 response, without adding reps
  • First response in seconds around the clock, against the minutes of the manual channel
  • Better inquiry-to-order conversion by responding on time with validated stock
  • Adverse event routed to pharmacovigilance in minutes with a pre-formatted ICSR
  • Fewer order-taking errors thanks to lot validation against the ERP

Key features for Big Pharma, biotech, generics, OTC, CROs and distribution:

  • B2B order taking with active lot validation (lot number, expiration, GS1 DataMatrix/NTIN/SNI serialization) against the ERP (SAP S/4HANA for Life Sciences, Oracle E-Business Suite, Microsoft Dynamics 365, Infor CloudSuite Industrial); automatic application of tiered price lists, minimum order quantities by wholesaler, volume rebates and active promotions; blocking of orders outside commercial policy
  • Automatic detection of adverse-event vocabulary (reaction, allergy, discomfort after administration, rash, anaphylaxis, lack of efficacy) with the opening of a pre-formatted ICSR case in E2B(R3) format, capture of minimum data with de-identification (patient initials, age, sex, lot, administration date, description of the event, severity, outcome), submission to Oracle Argus Safety / Veeva Vault Safety / ArisGlobal with an auditable timestamp, and notification to the PV lead in minutes
  • Identification of HCO/HCP accounts by tax ID, customer number, address or previous order reference; lookup of medical visit history, prior orders, active commercial terms and prescriber patterns against Veeva CRM, Salesforce Life Sciences Cloud, IQVIA, Komodo Health or Flatiron
  • Coordination of cold-chain products (refrigerated 2-8°C, ultra-cold -70°C for mRNA vaccines and cell therapies) with routing to the logistics team to confirm the delivery window, a vehicle with a calibrated thermal chamber and an active Sensitech/Controlant datalogger
  • Management of controlled products (psychotropics, narcotics) requiring supporting documents (filed prescription, purchase order signed by the responsible pharmacist/technical director, license number) before processing; automatic blocking if any requirement is missing, with routing to the regulatory commercial team
  • Structured technical inquiries for medical devices (measurements, compatibilities, sterile presentations, serial number) with routing to a specialist when the case warrants it; quoting hospital bid documents and tenders against locked-in contracts
  • Support for medical visits with touchpoint logging in Veeva CRM (when a physician asks a question outside the rep's schedule, the agent responds with approved information and books a visit if the inquiry requires human intervention)
  • Support for patients in programs with informed consent specific to DCT (Decentralized Clinical Trials) and adherence programs, within the GCP framework and with templates approved by the protocol's ethics committee
  • Escalation to the responsible rep or KAM when confidence in the response falls below a configurable threshold, with full conversation context and a transparent handoff for the customer
  • Compliance with ANMAT Disposition 5039/2019 GMP, Law 16,463 on Medicines, Law 25,326 on personal data, ANVISA RDC 301/2019 and RDC 406/2020, COFEPRIS NOM-059/NOM-220, INVIMA Resolution 1403/2007, ISP Decree 3/2010, DIGEMID DS 016-2011-SA, FDA 21 CFR Part 11, DSCSA, HIPAA when applicable, ICH GCP/GVP, GAMP 5 category 4 (configurable) with a full validation package (URS, FS, DS, IQ, OQ, PQ)

An OTC line with thousands of weekly inquiries, classifying intent and routing PV in minutes

What practical value you'll find when you open this section

Consider a multi-brand OTC line whose relaunch campaign for an analgesic brand generates thousands of weekly inquiries on social media and WhatsApp, where half go unanswered and the team doesn't distinguish information requests from B2B orders.

With Sellium the agent classifies intent (information, complaint, B2B order, adverse event), responds with material approved by regulatory affairs and routes adverse events to pharmacovigilance with the pre-formatted ICSR, aiming to cover the full volume of inquiries and take PV routing from hours down to minutes.

Accompanied medical visits and medical devices with structured technical inquiries

What practical value you'll find when you open this section

Sellium accompanies the rep in the field, it doesn't replace them.

When a physician, pharmacist or hospital purchasing manager asks a question outside the rep's schedule, the agent responds with information approved by medical affairs and books a visit if the inquiry requires human intervention.

Every interaction is logged to the rep's visit cycle in Veeva CRM or Salesforce Life Sciences Cloud.

For medical device manufacturers and distributors, Sellium handles structured technical inquiries (measurements, compatibilities, sterile presentations), quotes and routes to a specialist when warranted, without losing the thread of the conversation.

For hospital distribution with tenders and bid documents, the agent takes tender numbers, validates the associated bid document, confirms locked-in prices and delivery terms defined in the contract.

REVIO FOR PHARMACEUTICAL

HCP campaigns and regulatory recall with open rates far above email and withdrawal confirmation within the regulatory deadline

More effective HCP reach than email and recall within the regulatory deadline with documented confirmation

Revio communicates with HCPs using material approved by Veeva Vault PromoMats, executes regulatory recalls with a pre-approved template and reactivates wholesalers through a channel read far more than mail. It complies with ANMAT, ANVISA RDC 406/2020 and the PhRMA code.

Request a REVIO demo

Dato clave

Revio is the one that executes the recall to hospital pharmacies in hours, not days, and talks to the HCP through a channel that actually gets opened.

It is the manufacturer's direct channel to its network of HCPs, distributors, hospital pharmacies and wholesalers: medical visit campaigns with material approved by Veeva Vault PromoMats, segmented by specialty/territory/therapeutic line, invitations to symposia and congresses, medical notifications (DHCPC), regulatory recalls and pharmacovigilance alerts with a template pre-approved by regulatory affairs, communication to CROs and sponsors in DCT trials, indirect-channel campaigns and logistics communication (stock-outs, expirations, cold chain).

All under valid pharmaceutical opt-in, templates approved by WhatsApp and by regulatory affairs, and an auditable record of every send.

Big Pharma communicating a new approved indication to prescribers through a channel they actually open

What practical value you'll find when you open this section

Consider a Big Pharma manufacturer with a medical visit network that today communicates a newly approved indication to its prescribers by email (with the 20-25% real-world open rate industry studies report) and by medical visit, where full coverage takes weeks.

With Revio (a campaign segmented by specialty and region, using material approved by Veeva Vault PromoMats), the communication leverages WhatsApp open rates that industry studies put between 75% and 98% (Bird 2024; Brevo 2026), generates direct responses from HCPs requesting more information and lets the team prioritize visits, aiming to cover the network in a fraction of the time.

Or a generics manufacturer with a network of thousands of wholesalers whose monthly rebate communication is handled by a telesales team over days: with Revio the message goes out in one morning, gets read far more than the mail, and the telesales team is reassigned to higher-value tasks.

Key automations

  • Typical results in Pharmaceutical:
  • More effective HCP reach: industry studies put WhatsApp at 75-98% vs. 20-25% real-world for email (Bird; Brevo)
  • Regulatory recall executed within the health authority's deadline (FDA requires Class I action within 24 hours, 21 CFR Part 7) with documented confirmation
  • Lower cost per HCP confirmed at a scientific event than with an agency or telesales

Better adherence to the rep's medical visit reminders

  • PV/recall communication coverage confirmed by HCPs in hours, not weeks
  • A distributor executing an ANMAT recall to its hospital pharmacy network within the regulatory deadline
  • Consider a pharmaceutical distributor facing a regulatory recall: the health authority requires withdrawing a lot for a deviation in a biologic product, against deadlines measured in hours (the FDA requires initiating action on a Class I recall within 24 hours, 21 CFR Part 7). Making that communication to a network of hospital pharmacies by email and phone can barely meet the deadline, and leaves you without knowing how many confirmed the withdrawal. With Revio the flow becomes: the campaign goes out within a couple of hours using a template pre-approved by regulatory affairs, pharmacies confirm reading and physical withdrawal by WhatsApp with quantity withdrawn and the responsible pharmacist, and the case is left with an auditable timestamp to demonstrate deadline compliance to the authority. Common campaign types in pharma:
  • Communication to HCPs segmented by specialty/territory/visit cycle/prescriber profile/therapeutic line with material approved by Veeva Vault PromoMats and current regulatory references

Invitations to medical symposia, advisory boards and congresses with in-chat confirmation and attribution

What practical value you'll find when you open this section

Regulatory recall (voluntary withdrawal, forced withdrawal by health authority) with a pre-approved template, read confirmation and documented physical withdrawal for ANMAT/FDA/ANVISA/COFEPRIS audits

Smart automations

  • Approved package insert changes, pharmacovigilance alerts and DHCPC (Dear Healthcare Provider Communication)
  • Operational communication to CROs and sponsors: monitoring visit reminders, protocol alerts, amendments, medication-taking reminders in DCT (Decentralized Clinical Trials), clinical kit shipment notices
  • Indirect-channel commercial campaigns: monthly rebates to wholesalers, month-end closing reminders, new presentation launches, reactivation of dormant accounts
  • Logistics communication: stock-outs, products nearing expiration, cold chain entering the chamber, regulatory agency updates
  • Real-World Evidence campaigns with segmentation enriched from IQVIA, Komodo Health and Flatiron

Compliance with ANMAT drug promotion rules, ANVISA RDC 406/2020, COFEPRIS NOM-220, FDA, the PhRMA code, Law 16,463, EMA guidelines, documented pharmaceutical opt-in and immediate, immutable opt-out

What practical value you'll find when you open this section

Event-triggered sends from Oracle Argus, MasterControl, TrackWise and SAP ATTP / TraceLink

ARCONTE FOR PHARMACEUTICAL

Regulatory IDP for batch records, CoAs, ICSRs and FDA Form 483 observations with GAMP 5 and ALCOA+

Batch records, CoAs and ICSRs with an ALCOA+ audit trail and GAMP 5 category 4 validation

Arconte processes hundreds-of-pages hybrid batch records with their critical data, CoAs from 80-plus suppliers with OOS detection, ICSRs into E2B(R3) in minutes, and FDA Form 483 observations with a pre-formatted CAPA in TrackWise.

Request a ARCONTE demo

Dato clave

Arconte is the one that releases the lot without QA losing two weeks transcribing paper by hand.

It combines modern OCR with language models (IDP) to read and extract data from any pharmaceutical document with a confidence score per field, an exceptions queue, an immutable audit trail, and GAMP 5 category 4 (configurable) compliance with ALCOA+ integrity, with no templates or fixed-position rules.

In pharma it processes the sector's massive document universe: batch records, certificates of analysis, LIMS results, cold chain reports, clinical trial source documents, pharmacovigilance ICSRs, regulatory observations and API invoice matching.

A biologics manufacturer with a hundreds-of-pages batch record pre-reviewed by AI to speed up release

What practical value you'll find when you open this section

Consider a biologics manufacturer releasing a lot, where the batch record for a monoclonal antibody includes hundreds of pages with fermentation, purification, formulation, raw material CoA and QC results data, and QA takes days to review and transcribe it into the system.

With Arconte the package is loaded on day zero, Arconte extracts the critical data in minutes, flags deviations for human review, compares it against spec, and delivers a pre-reviewed summary to the QP, aiming to significantly shorten the release cycle.

That direction of improvement is well documented: McKinsey reports that digitizing quality control in pharma can add 30-40% productivity, cut QC costs by more than 50%, lower deviations by more than 65% and speed up deviation closure by more than 90% (McKinsey 2020-2024).

Or a generics manufacturer matching API invoices, whose accounts payable team processes thousands of monthly invoices for APIs and excipients from dozens of suppliers in heterogeneous formats, with a material error rate; industry benchmarks put the cost of manually processing an invoice around USD 9.40 on average (Ardent Partners 2025).

With Arconte the matching against the purchase order and goods receipt is automatic, the invoice gets approved in minutes with fewer coding errors, and the team is reassigned to financial analysis while days-payable improves.

With Arconte:

  • Hybrid batch records (paper plus Werum PAS-X / Rockwell PharmaSuite) with extraction of fermentation, purification, formulation and IPC (in-process control) data, LIMS results, comparison against specifications, flagging of deviations (minor, major, critical), identification of missing data, and preparation of the pre-reviewed package for the QP (Qualified Person)
  • Certificates of Analysis (CoA) and Certificates of Compliance (CoC) from API and excipient suppliers in heterogeneous formats, with extraction of purity, method-by-method analytical results (HPLC, GC, IR, DSC, KF), validation against the manufacturer's spec, detection of OOS (Out-of-Specification) and OOT (Out-of-Trend), and automatic lot blocking in SAP/Oracle upon confirmed OOS
  • ICSRs (Individual Case Safety Reports) from any format (email, PDF, fax, handwritten form, medical visit report, WhatsApp) into E2B(R3) ready to load into Oracle Argus Safety, Veeva Vault Safety or ArisGlobal, with classification (spontaneous, medical, information request), extraction with de-identification (initials, age, sex, lot, date, description, severity, outcome), MedDRA coding and a pre-formatted narrative
  • Regulatory inspection observations (FDA Form 483, ANMAT deficiencies, COFEPRIS demands, EMA observations, ANVISA) with classification by criticality and impacted system, feeding the CAPA system (TrackWise, Veeva QualityOne, Sparta Systems TrackWise Digital, MasterControl) with pre-formatted context
  • Clinical trial source documents (scanned PDFs, handwritten site forms) with extraction of critical patient data with de-identification, vital signs, drug exposure, adverse events detected during monitoring, ICSR building when applicable, reconciliation against the eCRF (Veeva Vault EDC, Medidata Rave, Castor) with automatic queries and reduced query resolution time
  • Cold chain reports and Sensitech/Controlant/monnit/Berlinger dataloggers with detection of temperature excursions, cross-check against product specification, flagging of the affected lot, and automatic quarantine trigger in the ERP (SAP S/4HANA, Oracle E-Business Suite)
  • Three-way matching of API/excipient invoices against the purchase order and goods receipt (validation of quantity/price/lot/CoA matches), reduced days-payable and coding errors with load to the ERP
  • Incoming electronic regulatory dossiers (Common Technical Document) for cross-affiliate review; reading and categorization of distribution contracts, hospital bid documents and FDA Warning Letters
  • Aggregation reports and serialization documentation (NTIN, SNI, GS1 DataMatrix, GLN, GTIN) for DSCSA compliance, the EU Falsified Medicines Directive and ANMAT 3683/2011 traceability
  • GAMP 5 category 4 (configurable) compliance with a full validation package (URS, FS, DS, IQ, OQ, PQ, risk analysis, change control, revalidation) and ALCOA+ integrity by design (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available)

Typical results:

  • Faster batch release with a pre-reviewed package and flagged deviations (McKinsey puts the impact of digitizing QC at more than 65% fewer deviations and more than 90% faster closure; 2020-2024)
  • Fewer capture errors with automatic cross-validation against spec
  • ICSR structured to a pre-formatted E2B(R3) in minutes instead of manual entry
  • Inspection preparation in hours, not weeks, with indexed documents
  • Better days-payable on API invoices with automatic three-way matching

A CRO in a multi-site phase III trial with accelerated reconciliation of source documents against the CRF

What practical value you'll find when you open this section

Consider a CRO running a multi-site phase III trial, where monitoring dozens of sites across Latin America means every CRA has to travel or request scans of source documents to verify against the CRF, with weeks of monitoring backlog.

With Arconte, sites upload source documents to the study portal, Arconte extracts visit data, vital signs, drug exposure and adverse events, reconciles them with the CRF in Veeva Vault EDC and flags discrepancies, enabling remote monitoring of most of the volume, saving CRA travel costs and shortening query resolution time.

For regulatory inspections and incoming dossiers, Arconte processes FDA Form 483 observations, ANMAT deficiencies and COFEPRIS demands, classifies them by criticality and impacted system, and feeds the CAPA system with pre-formatted context, cutting document preparation time for an inspection from weeks to hours with documents indexed by lot, product, supplier, document type and date.

METRIX FOR PHARMACEUTICAL

Conversational BI on OEE, RFT, batch yield, query rate and IQVIA market share without altering ALCOA+ integrity

OEE, RFT, batch yield, query rate and IQVIA market share without altering ALCOA+ integrity

Metrix unifies Werum PAS-X, LabWare, Argus, Veeva, SAP S/4HANA and IQVIA/Komodo market data so directors and QPs get answers in seconds from their phone with an audit trail per query.

Request a METRIX demo

Dato clave

Metrix is the BI that answers OEE or market share questions over WhatsApp without touching the source data's ALCOA+ integrity.

From the Head of Quality to the QP, from the Head of Commercial to the technical director, anyone can query operational, clinical, quality and regulatory KPIs in natural language over validated GxP systems, with an audit trail for every query and respect for the inherited permission model.

We connect the MES (Werum PAS-X, Siemens Opcenter, Rockwell PharmaSuite), LIMS (LabWare, Thermo Fisher SampleManager, STARLIMS), quality systems (MasterControl, TrackWise, Sparta Systems TrackWise Digital, Veeva QualityOne), pharmacovigilance (Oracle Argus Safety, Veeva Vault Safety, ArisGlobal), clinical platforms (Veeva Vault EDC, Medidata Rave, Oracle Health Sciences, Castor, Florence eBinders), CRM (Salesforce Life Sciences Cloud, Veeva CRM), ERP (SAP S/4HANA for Life Sciences, Oracle E-Business Suite, Microsoft Dynamics 365, Infor CloudSuite Industrial), traceability (SAP ATTP, TraceLink, Systech), cold chain (Sensitech, Controlant, monnit, Berlinger), market data (IQVIA, Komodo Health, Flatiron, RWE/RWD) and legacy BI (Power BI, Tableau, Qlik, ThoughtSpot).

Critically: Metrix is a query layer, not a transformation layer.

Data still lives in Werum, LabWare, Argus and SAP.

Metrix reads, presents and builds the visualization, but never writes or alters the source data.

For the Head of Manufacturing, Head of Quality, QP, Head of Pharmacovigilance, Head of Clinical Operations, Head of Commercial, Head of Medical Affairs, Head of Supply Chain, Head of Market Access and Compliance Officer

What practical value you'll find when you open this section

Decisions that used to wait for Monday's 11 AM report now happen in real time.

Some questions Metrix answers for different roles in the sector:

Head of Manufacturing / Plant Director

What's purification line 2's OEE?

What's the lot's batch yield?

What's RFT for the last 5 lots?

Unplanned stops this week?

Head of Quality / QP

What's the deviation rate by line?

CAPA cycle time?

OOS rate by product?

Regulatory inspection status?

Documentary Right-First-Time?

Head of Pharmacovigilance

PV cases by product?

Average ICSR closure time?

Signals under evaluation?

Expedited reports compliance?

Head of Clinical Operations

Enrollment rate by site?

Screen failure rate by country?

Veeva EDC query rate?

Data lock projection?

Head of Commercial

Sell-in vs. sell-out by quarter?

Share of voice by specialty?

Market share vs. IQVIA competitors?

HCP coverage by territory?

Head of Medical Affairs

Therapeutic adoption by geography? · KOL engagement? · Paper citations? · Advisory board feedback?

Access from WhatsApp/Slack/Teams/web for directors, QPs and middle managers without going through traditional BI (traditional BI adoption stalls at 25-35% of employees according to Gartner and BARC, and a conversational channel aims to widen that reach with more frequent queries)

Structural benefits

  • Head of Supply Chain: DOH by SKU? · Distribution OTIF? · % shipments within thermal range? · Lots nearing expiration? · Value tied up in quarantine?
  • Head of Market Access: Hospital formulary coverage? · Reimbursement rate? · RWE therapeutic adoption? · Payer mix?
  • Structural benefits for pharma
  • A single source of truth with no arguments between commercial, finance, trade, plant and quality over the correct OEE/RFT/sell-in/share number, backed by a unified semantic layer that translates 'sales' or 'lot' or 'share of voice' into single, approved technical definitions
TRAZZO FOR PHARMACEUTICAL

Last mile with 2-8°C and ultra-cold -70°C cold chain monitored live with Sensitech/Controlant

2-8°C and ultra-cold -70°C cold chain with Sensitech/Controlant and POD with GS1 DataMatrix

Trazzo coordinates deliveries to hospital pharmacies, wholesalers and DCT patients with minute-zero monitoring, GCP-ready chain of custody and serialized traceability for ANMAT/FDA/EMA audits.

Request a TRAZZO demo

Dato clave

Trazzo is the one that catches the temperature excursion at minute zero, not after the hospital has already rejected the box.

A pharmaceutical delivery is not just any delivery: it's the biologic refrigerated at 2-8°C that has to reach the hospital pharmacy before 11:00 AM with the datalogger intact, the DCT clinical trial kit that requires documented chain of custody for ANMAT/FDA audits, or the ultra-cold -70°C mRNA vaccine needing dry-ice re-icing en route.

Trazzo orchestrates that last mile with AI: it plans the route respecting the thermal window and the hospital's receiving window, assigns a certified driver and a vehicle with a calibrated chamber, monitors temperature every 1-5 minutes via Sensitech or Controlant and fires the alert the moment of the excursion (not when the datalogger is downloaded), captures the pharmacist-signed POD, reads the GS1 DataMatrix on each unit, and leaves the complete chain of custody for audit.

A biologics distributor to a hospital pharmacy, with the temperature excursion caught at minute zero

What practical value you'll find when you open this section

Consider a biologics distributor that today builds Friday routes in Excel for a Monday delivery, with no visibility into temperature excursions until the datalogger is downloaded when the truck returns: a box of Trastuzumab that arrives out of range gets rejected two days later, with lost product and a liability dispute.

With Trazzo, routing is automatic factoring in the hospital's receiving windows, with live thermal monitoring and a minute-zero alert on any deviation, aiming to eliminate excursion rejections and lower logistics costs.

Or a regional wholesaler with hundreds of daily deliveries whose route planning is done every morning by a team using rules of thumb: with Trazzo, routing is solved in minutes, with a live OTIF dashboard, better delivery compliance and fleet savings.

With Trazzo:

  • AI-driven route optimization respecting thermal windows (refrigerated 2-8°C, ultra-cold -70°C for mRNA vaccines and cell therapies, controlled ambient 15-25°C), hospital Pharmacy Service receiving windows (typically Monday to Friday 8:00-11:30 AM and 2:00-4:30 PM), the hospital's temperature-controlled storage capacity, clinical priority of the medication (urgent vs. scheduled), real traffic, and vehicle transit restrictions (weight, dimensions, low-emission zones)
  • Dynamic driver assignment with medication-transport certification, a vehicle with a calibrated thermal chamber, and availability for capturing the digital POD signed by the on-duty pharmacist
  • IoT cold chain with real-time monitoring: native integration with Sensitech TempTale Cloud API, Controlant Saga Platform, monnit, ELPRO, Berlinger Smartview, Cryopak, with temperature reported every 1-5 minutes and immediate alerts on excursion (not a late discovery when the datalogger is downloaded on the truck's return)
  • Automated return-to-DC protocol on a temperature excursion that compromises product per the manufacturer's QA rules: delivery block, event documented in TrackWise/MasterControl, lot quarantine
  • Serialized traceability compatible with ANMAT Disposition 3683/2011, US DSCSA, EU FMD/EMVS, ANVISA Brazil, COFEPRIS Mexico, DIGEMID Peru; integration with TraceLink, SAP ATTP, Systech UniSecure, rfXcel for SNI/GS1 DataMatrix validation at load and delivery scanning
  • DCT (Decentralized Clinical Trials) kits with GCP-ready chain of custody from the investigator site to the patient or from the patient to the central lab; identification by study ID (not name), patient/caregiver signature, timestamped geolocation, an auditable report attachable to the CRF in Veeva Vault CTMS / Medidata RTSM
  • Digital proof of delivery signed by the responsible pharmacist with scanned ID, package photo, GS1 DataMatrix read on each unit, geolocation and timestamp; receipt emailed in under 30 seconds
  • Channel visibility for medical visits: if Trazzo is integrated with Veeva CRM or Salesforce Life Sciences Cloud, the rep sees the hospital pharmacy account's last order status, date/time, delivered lots and incidents in their own account view, avoiding the rep-logistics-carrier triangulation
  • Operation with owned fleet, third-party carriers (3PL) and hybrid models: every driver (own or subcontracted) uses the Trazzo app on their phone with authentication, geofencing and a log
  • Compliance with ANMAT Disposition 5039/2019 and 3683/2011, FDA 21 CFR Part 11/210/211 and DSCSA, EMA, ANVISA RDC 301/2019 and 304, COFEPRIS, INVIMA, ISP, DIGEMID, ICH GDP (Good Distribution Practice), GAMP 5, WHO Prequalification, the EU Falsified Medicines Directive, GS1 Standards (DataMatrix, SNI, GTIN, GLN), and ALCOA+ principles in every logistics record

Typical results in Pharmaceutical:

  • Better delivery compliance (OTIF) with routing that respects thermal and receiving windows
  • More shipments within thermal range with live monitoring instead of late datalogger downloads
  • Lower cost per delivery from optimized routing and fewer kilometers
  • Fewer kilometers driven from smart consolidation and geographic optimization
  • Regulatory audit response time down from weeks to minutes
  • Fewer proof-of-delivery disputes with digital signature, geolocation and timestamp

A CRO with DCT kits for 14 sites and ultra-cold -70°C vaccines with dry-ice re-icing en route

What practical value you'll find when you open this section

Consider a regional CRO with several investigator sites, where today every kit shipment to an enrolled patient is coordinated by email between the CRA and the courier, and the proof of delivery is a WhatsApp photo the monitor files by hand, leaving deliveries with no verifiable documentation when an FDA audit comes up.

With Trazzo the flow becomes: end-to-end digital chain of custody, patient signature captured on site, and CTMS integration so the monitor sees the status without asking, aiming to leave every shipment with auditable traceability and shorten the response time to regulatory audit queries.

For ultra-cold -70°C mRNA vaccines and cell therapies, Trazzo supports specific dataloggers (Sensitech UltraFreeze, Controlant Crystal), stricter thresholds, a dry-ice re-icing protocol en route, and thermal container validation before departure, as a distinct operating mode from 2-8°C with its own alert and return rules.

VANTEGRATE ECOSYSTEM SYNERGIES

Where it really shows: when all five agents share the same GxP compliance

The value shows up when the products work together with a single GxP audit trail

Orders, HCP campaigns, batch records, ICSRs and refrigerated deliveries connect to create complete flows with no duplicated work and a single shared GAMP 5 validation package.

Vantegrate ecosystem

One AI Platform, Unified & Integrated
into every process and system in your company

Go-live in 4–8 weeksTypical ROI in 3–6 months24/7 operation · 6 countries
Vantegrate agent hubCentral AI engine connected to the five agents: Arconte, Sellium, Revio, Trazzo and Metrix.

Vantegrate

AI Platform

Arconte

-

Document AI

Sellium

-

WhatsApp Sales

Revio

-

WhatsApp Marketing

Trazzo

-

Logistics AI

Metrix

-

WhatsApp BI

IntelligenceConversationOperations

Regional coverage

Argentina
Mexico
Colombia
Chile
U.S.
Spain
Brazil
+ all of Latin America
Native languages🇪🇸 ES · 🇺🇸 EN · 🇧🇷 PT

Dedicated implementation

We are not self-service. We configure every agent with your rules and your integrations.

1Step 1: Demo and assessment
2Step 2: Proposal and kickoff
3Step 3: Go-live and ongoing support
35+ Integrations
MercadoPagoStripeWhatsApp Business APISAPOracle NetSuiteJD EdwardsDynamics 365Tango GestiónBejermanSalesforceHubSpotShopifyVTEXTiendanubeMercadoPagoStripeWhatsApp Business APISAPOracle NetSuiteJD EdwardsDynamics 365Tango GestiónBejermanSalesforceHubSpotShopifyVTEXTiendanube
Partners and platform standards
Salesforce PartnerOracle PartnerSOC 2 Type IIISO 27001PCI DSS99.9% SLA

Dato clave

A manufacturer, a biotech, a CRO or a distributor could buy five disconnected tools: a chatbot, a WhatsApp marketing platform, an IDP for batch records, a BI connected to the MES, and a specialized courier.

That would mean five contracts, five vendors, five implementations, five separate audit trails and, in pharma, five different surfaces where ANMAT/FDA/EMA/ICH compliance can break.

Dato clave

Vantegrate goes the other way: each agent was designed to hand the case to the next one respecting ALCOA+ integrity, GAMP 5 and ICH GxP by design.

These are the synergies that move the needle most in the sector:

Revio + Sellium

From regulatory recall to confirmed physical withdrawal within the deadline

Revio triggers the recall of Tacrolimus 5mg lot AX-2024-118 to the hospital pharmacy network with a template pre-approved by regulatory affairs, and within the first few hours most pharmacies confirm the read.

When the hospital pharmacy replies 'we have 38 units of that lot,' Revio hands the conversation to Sellium with the recall context: physical isolation, data capture for the regulatory record (quantity withdrawn, units dispensed in the last 7 days, the responsible pharmacist confirming), physical withdrawal coordination with logistics, and generation of case RC-2026-074 with an immutable timestamp.

The pharmacy goes from 'I read the notice' to 'units isolated and withdrawal confirmed' without switching windows, in documented compliance with the ANMAT regulatory deadline.

Sellium + Arconte

Adverse event detected on WhatsApp processed into an E2B(R3) ICSR in minutes

When a hospital pharmacist mentions on WhatsApp 'a patient had a skin reaction with lot A2601' to Sellium, the agent detects adverse-event vocabulary (reaction, allergy, rash) and opens the pharmacovigilance flow.

Sellium captures minimum data with de-identification (initials M.G., age 47, lot A2601, administration on 05/12, generalized rash within 6 hours), and Arconte processes the report, structuring it to E2B(R3), coding MedDRA, generating a pre-formatted narrative, and sending the ICSR to Oracle Argus / Veeva Vault Safety with an auditable timestamp.

The PV lead receives case FV-2026-1184 in minutes instead of the days manual entry takes, meeting the ANMAT/FDA/ANVISA regulatory deadline.

Sellium + Trazzo

Refrigerated order with monitored cold chain and digital POD with GS1 DataMatrix

When Sellium confirms a refrigerated Adalimumab order for the hospital pharmacy, Trazzo receives the order and plans a refrigerated delivery with a calibrated thermal chamber and an active Sensitech datalogger.

It monitors temperature every 5 minutes during the trip (4.2°C in transit, all within range), notifies the pharmacist when the truck is 14 minutes from the hospital due to a traffic delay, arrives at 10:04 AM with a final temperature of 4.8°C, captures the digital POD with the pharmacist's signature, scanned ID, package photo, GS1 DataMatrix reads on all 12 units and geolocation.

The complete digital chain of custody (DC departure, route, temperature every 5 minutes, driver, signed receipt with geolocation) is available for an ANMAT audit as a PDF in under 30 seconds.

Arconte + Metrix

Batch record processed with operational KPIs correlated in real time

The deviations Arconte detects in batch records (4 deviations in lot LT-2026-098 including 1 major from chamber C-3 temperature at 23.4°C for 7 minutes), supplier OOS (excipient lot ACE-447 with purity 99.3% vs.

spec 99.5%) and generated CAPAs (TrackWise-2026-451) are all consolidated into Metrix as quality and operations insight.

The Head of Quality asks 'what's the deviation rate by line this week?' and gets the table broken down by driver (temperature, CIP overpressure, pH sensor, QA OOT) and by production line, with drill-down to the specific lot and a proposed action.

Trazzo + Arconte

Digital chain of custody processed to validate delivery and GS1 traceability

The digital POD Trazzo generates on every pharmaceutical delivery (package photo, scanned GS1 DataMatrix on each unit, pharmacist signature, ID, geolocation, timestamp, and the complete thermal curve of the trip) is processed by Arconte to validate the match against the original order, update ANMAT 3683 traceability with serialized events (dispatch, transit, receipt), archive the evidence in document management (OpenText, M-Files, SharePoint, Box) and release billing to the customer.

For DCT clinical trials, the POD is automatically attached to the CRF in Veeva Vault CTMS / Medidata RTSM identified by study ID.

Metrix + everyone with ALCOA+ compliance

A 360 view of the manufacturer respecting GxP integrity

Metrix consumes the data generated by Sellium (channel order volume, adverse events routed, channel NPS, inquiry-to-order conversion), Revio (HCP campaign engagement, recall coverage, order attribution to rebate campaigns), Arconte (document processing time, deviations detected, CAPAs generated, ICSR throughput, API days-payable) and Trazzo (pharmaceutical OTIF, % shipments within thermal range, cost per delivery, kilometers driven, audit response time).

As a query layer, it never alters the source system's ALCOA+ integrity: data still lives in Werum, LabWare, Argus and SAP, and Metrix only reads, with an audit trail per query.

VALUE BY TYPE OF PHARMACEUTICAL BUSINESS

We design every implementation around the manufacturer's operating model

Big Pharma, biotech, generics and CROs need different focuses with their own compliance

Big Pharma with medical visits, biotech with refrigerated biologics, generics with an indirect channel, CROs with DCT trials, distributors with cold chain and medical devices with UDI share technology but not the same KPIs or the same regulatory requirements.

Dato clave

There is no such thing as a single "pharmaceutical company." Each sub-vertical and each operating model (global Big Pharma, biotech, generics manufacturer, OTC manufacturer, vaccine producer, CRO/clinical research sponsor, pharmaceutical distributor, wholesaler, medical device manufacturer, CMO/CDMO) has its own metrics, cycles, regulations and pain points.

That's why every Vantegrate implementation is custom designed with a specific GAMP 5 validation package, a compliance posture inherited from the client (Salesforce or Oracle Cloud Infrastructure), and escalation rules adapted to the manufacturer's protocol.

For Big Pharma and biotech with medical visits and biologic/vaccine products

What practical value you'll find when you open this section

The focus is on HCP coverage by specialty/territory/visit cycle, share of voice by therapeutic line, market share against IQVIA competitors, therapeutic adoption by geography, PV routing in minutes, biologic lot release in 36 hours vs.

9 days, 2-8°C or ultra-cold -70°C cold chain monitoring for mRNA/cell therapies, and FDA 21 CFR Part 11/EMA/ICH compliance.

Vantegrate logs every touchpoint in Veeva CRM, communicates a new indication over WhatsApp with open rates far above email, processes batch records with deviation detection, measures OEE/RFT by line, and orchestrates cold chain with Sensitech UltraFreeze and Controlant Crystal.

For generics and OTC manufacturers with an indirect channel and a wholesaler network

What practical value you'll find when you open this section

The focus is on more indirect-channel coverage, better inquiry-to-order conversion, reactivation of dormant wholesalers, capturing orders outside business hours, three-way matching of API invoices, and operating margins by SKU.

Vantegrate takes B2B orders over WhatsApp with lot validation, communicates monthly rebates through a channel read far more than mail, processes CoAs from 80-plus suppliers in heterogeneous formats with OOS detection, and measures sell-in/sell-out/share in natural language.

For CROs and clinical research sponsors with DCT trials

What practical value you'll find when you open this section

The focus is on enrollment rate by site, screen failure rate by country, query rate and query resolution time, data lock projection, GCP-ready chain of custody for DCT clinical kits, reconciliation of source documents against the eCRF (Veeva Vault EDC, Medidata Rave, Castor), and ICH GCP/21 CFR Part 11 compliance.

Vantegrate coordinates monitoring visit reminders, processes source documents with automatic reconciliation against the CRF that shortens query resolution, measures enrollment/queries/data lock in real time, and orchestrates kit shipments to sites and patients with a GCP-ready digital chain of custody.

For pharmaceutical distributors and wholesalers with cold chain

What practical value you'll find when you open this section

The focus is on better delivery compliance (OTIF), more shipments within thermal range, lower cost per delivery, fewer kilometers driven, route planning time down from hours to minutes, a lower non-delivery rate from closed windows, and ANMAT/FDA/ANVISA audit response time.

Vantegrate handles 24/7 stock inquiries against the ERP, executes recalls within the health authority's deadline with documented confirmation, processes hospital delivery notes and cold chain reports with excursion detection, and orchestrates the last mile with IoT monitoring via Sensitech/Controlant.

For medical device manufacturers and distributors

What practical value you'll find when you open this section

The focus is on managing structured technical inquiries (measurements, compatibilities, sterile presentations, serial number), coordinating scheduled hospital deliveries aligned to the surgical calendar, FDA 21 CFR Part 820/EU MDR/ANMAT compliance, and UDI (Unique Device Identification) traceability.

Vantegrate handles technical inquiries with routing to a specialist, communicates regulatory recalls with documented confirmation, processes UDI regulatory documentation, and orchestrates deliveries with notification to the hospital supply room.

For regulatory affairs, quality and pharmacovigilance

What practical value you'll find when you open this section

The focus is on regulatory inspection preparation (FDA Form 483, ANMAT deficiencies, EMA observations), CAPA cycle time, ICSR throughput, expedited reports compliance (15 days, 30 days depending on severity), signal detection, and aggregate reports (PSUR, PBRER, DSUR).

Vantegrate processes observations with a pre-formatted CAPA in TrackWise/Veeva QualityOne, routes adverse events to Argus/Vault Safety with E2B(R3) in minutes, and measures deviation rate, CAPA cycle time, ICSR throughput and inspection status in natural language.

WHY VANTEGRATE

We don't sell you a license: we leave the AI running with native GxP compliance

We don't sell software: we deliver artificial intelligence implemented with native GxP compliance

Our team configures, integrates, delivers the complete GAMP 5 package (URS/FS/DS/IQ/OQ/PQ) and supports ANMAT/FDA/EMA inspections, regulatory updates (DSCSA, EU FMD, EU AI Act) and periodic revalidation.

Dato clave

The market is full of self-service platforms that promise a lot and deliver little: a low fee and then, configure it, integrate it, train it, maintain it, and, in pharma, guarantee your own ANMAT/FDA/EMA/ICH/GxP/GAMP 5/ALCOA+ compliance.

Given time, a technical team and a dedicated Compliance Officer, something eventually works.

But a poorly executed GAMP 5 validation is an inspection observation, and an ICSR not routed on time is a regulatory sanction: it isn't optional.

Dato clave

Vantegrate is something else.

We are a premium implementation team with experience across Big Pharma, biotech, generics, OTC, vaccines, CROs and clinical research sponsors, pharmaceutical distributors, wholesalers, medical devices and CMO/CDMO operators in Latin America and the United States.

We take the measurements, configure the suite with native regulatory compliance, integrate with Salesforce Life Sciences Cloud, Veeva (CRM and Vault Safety/QualityOne/EDC/PromoMats), Oracle Argus, MasterControl, TrackWise, Werum PAS-X, LabWare, SAP S/4HANA for Life Sciences, TraceLink, Sensitech, Controlant and whatever you already run, and we deliver the full GAMP 5 validation package (URS, FS, DS, IQ, OQ, PQ) so your QA team executes the operational validation and keeps the dossier for audit.

We stay on as an operating partner, including inspection prep and regulatory updates.

What sets us apart

Seven pillars that define how we work in the pharmaceutical industry with native GxP compliance

Managed implementation with a GAMP 5 package from day one

The client only validates and approves. We deliver URS, FS, DS, IQ, OQ, PQ, risk analysis, change control and revalidation; the manufacturer's QA team executes the operational validation.

Native integration with Veeva, Salesforce LSC, Oracle Argus, Werum and MasterControl

For manufacturers already running those systems, we come in as first-class citizens via native API, without replacing the CRM, Vault Safety/QualityOne/EDC/PromoMats, MES, LIMS, quality systems or serialization.

ALCOA+ integrity by design with an immutable audit trail

Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available. Every Arconte extraction, every Metrix query and every Sellium/Revio/Trazzo interaction is left with a confidence score and traceability.

Focus on mid-sized and large Big Pharma, biotech, generics, CROs and distribution

We don't serve thousands of small accounts; we serve a few pharmaceutical players in depth, with knowledge of all six sub-verticals and each health authority's specific regulation.

A complete suite, a single partner with a single validation package

Conversational orders with PV, HCP campaigns, regulatory IDP, conversational BI over GxP data and last mile with cold chain, integrated in one project, one team, one contract.

Verifiable results with sector KPIs

Indirect-channel coverage, PV routing, HCP reach, recall execution, batch release cycle, ICSR throughput, OEE/RFT, query resolution time, pharmaceutical OTIF, % shipments within thermal range, audit response time.

Continuous support with inspections and regulatory updates

We don't abandon the operation after launch. We support ANMAT/FDA/ANVISA/COFEPRIS/EMA/WHO PQ inspections, updates (DSCSA, EU FMD, IDMP, EU AI Act) and periodic revalidation.

Security and compliance

International certifications (SOC 2 Type II, ISO 27001, GxP-ready) inherited from Salesforce Life Sciences Cloud or Oracle Cloud Infrastructure (GxP-validated Oracle Argus). Comprehensive regulatory compliance: ANMAT in Argentina, ANVISA in Brazil, COFEPRIS in Mexico, INVIMA in Colombia, DIGEMID in Peru, ISP in Chile and FDA 21 CFR Part 11 in the US, plus global GxP standards (GMP/GLP/GCP/GDP/GVP), ICH Q7-Q10, GAMP 5, ALCOA+ data integrity, GS1 for serialization and GDPR for clinical data. We add Meta's WhatsApp Business policies. For an operation with GxP batch records, patient clinical data, ICSRs under regulatory deadlines and multi-country inspections, that isn't optional: it's a requirement.

SOC 2ISO 27001GAMP 521 CFR Part 11GxP-readyAES-256
View policy
Other platforms
Vantegrate

The client configures, integrates and validates under GAMP 5 with its own team

Managed implementation with a complete GAMP 5 package from day one

APIs and connectors the IT team resolves with no regulatory context

Native integration with Veeva, Salesforce LSC, Oracle Argus, Werum, MasterControl

Generic chatbots with no adverse event routing to Argus

ICSR pre-formatted in E2B(R3) toward Argus/Vault Safety in minutes

Thousands of accounts with standardized attention and no GxP

A few pharmaceutical players with native ALCOA+ and GAMP 5 compliance

Five tools with five audit trails and five separate validations

Orders, mass comms, IDP, BI and cold chain with a single validation package

The vendor disappears after launch with no inspection support

An operating partner in every ANMAT/FDA/EMA inspection and revalidation

Verifiable results of artificial intelligence in the pharmaceutical industry

Verifiable indicators with GxP compliance and GAMP 5 validation

Every implementation starts from a baseline and is evaluated with concrete pharmaceutical business KPIs, respecting the source system's ALCOA+ integrity by design.

Every implementation is measured for maximum results with native GxP compliance. These are the fronts where our sector clients see consistent improvements when adopting the full suite:

In channel and conversational support (Sellium)

What practical value you'll find when you open this section

  • More indirect-channel coverage with 24/7 response, without adding reps
  • First response in seconds around the clock, and better inquiry-to-order conversion
  • PV routed to Argus in minutes with a pre-formatted E2B(R3) ICSR
  • Fewer order-taking errors with lot/spec validation against the ERP

In mass communication (Revio)

What practical value you'll find when you open this section

  • More effective HCP reach: industry studies put WhatsApp at 75-98% vs. 20-25% real-world for email (Bird; Brevo)
  • Regulatory recall within the health authority's deadline (FDA requires Class I action within 24 hours, 21 CFR Part 7) with documented confirmation
  • Lower cost per HCP confirmed at a scientific event than with an agency or telesales
  • Better adherence to medical visit reminders

In administrative processes (Arconte)

What practical value you'll find when you open this section

  • Faster batch release with pre-reviewed batch records (McKinsey puts the impact of digitizing QC at more than 65% fewer deviations and more than 90% faster closure; 2020-2024)
  • ICSR structured to a pre-formatted E2B(R3) in minutes instead of manual entry
  • Better days-payable on API invoices with automatic three-way matching
  • Better documentary Right-First-Time with automatic cross-validation against spec

In decisions and business intelligence (Metrix)

What practical value you'll find when you open this section

  • C-Suite operating questions answered in seconds instead of days
  • Faster monthly commercial close with live consolidation
  • Higher executive and middle-management adoption via a conversational channel (traditional BI adoption stalls at 25-35%; Gartner, BARC)
  • Inspection/audit ad-hoc request response time down from weeks to minutes

In pharmaceutical last mile (Trazzo)

What practical value you'll find when you open this section

  • Better delivery compliance (OTIF) with routing that respects thermal and receiving windows
  • More shipments within thermal range with live monitoring
  • Lower cost per delivery and fewer kilometers driven from optimized routing
  • Regulatory audit response time down from weeks to minutes

We show you how this lands in your channel and your pharmacovigilance, not in a generic manufacturer

A personalized demo with diagnosis and a GAMP 5 validation package

The first conversation identifies regulatory and operating friction points, prioritizes products respecting GxP compliance, and projects returns with data from your specific case.

Dato clave

We don't do canned demos.

The first conversation is a working session: we understand your model (Big Pharma, biotech, generics, OTC, vaccines, CRO/sponsor, distributor, medical devices, CMO/CDMO), your sub-vertical (direct-to-HCP channel, indirect channel via wholesalers, hospital fulfillment, DCT trials, in-house/outsourced manufacturing), your core systems (Veeva, Salesforce LSC, Oracle Argus, Werum PAS-X, MasterControl, SAP) and your specific regulatory friction points (ANMAT, FDA, EMA, ANVISA, COFEPRIS, INVIMA, ISP, DIGEMID).

We flag which agents would give you the most impact and project results with your own numbers: channel coverage, PV routing, HCP reach, recall execution, batch release, ICSR throughput, OEE, OTIF, % thermal range.

Anyone who requests a personalized demo walks away with

What practical value you'll find when you open this section

  • A clear diagnosis of the friction points in their pharmaceutical operation with native GxP compliance
  • A prioritized recommendation of which AI Platform products to implement first, respecting GAMP 5 validation
  • A return-on-investment projection calculated with their own data and the sector's KPIs
  • An implementation plan with timeline, GAMP 5 validation package and specific integrations, aligned to regulatory inspections and regulatory updates
  • Want to learn more about pricing and engagement models? Our team puts together a tailored proposal after the discovery session.
Preguntas frecuentes

Frequently asked questions about artificial intelligence for the pharmaceutical industry with GxP compliance

The essentials to understand how Vantegrate is implemented across global Big Pharma, biotech, generics manufacturers, OTC manufacturers, vaccine producers, CROs and clinical research sponsors, pharmaceutical distributors, wholesalers, medical device manufacturers and CMO/CDMO operators, with a GAMP 5 category 4 validation package, ALCOA+ integrity by design, and a compliance posture inherited from Salesforce or Oracle Cloud Infrastructure.

Platform

What kind of pharmaceutical companies can use Vantegrate?

Vantegrate is built for the six typical sub-verticals of the sector: global Big Pharma and biotech (biologic products, mRNA vaccines, cell and gene therapies, oncology), generics and OTC manufacturers (high-volume indirect channel, wholesalers and retail pharmacy), CROs and clinical research sponsors (phase I-IV trials, DCT - Decentralized Clinical Trials, investigator sites), pharmaceutical distribution and wholesalers (2-8°C and ultra-cold -70°C cold chain, hospital pharmaceutical retail), medical device manufacturers and distributors (FDA 21 CFR Part 820, EU MDR, ANMAT) and CMO/CDMO operators (contract manufacturing, fill-finish). It applies to operations running on the Veeva stack (CRM, Vault Safety/QualityOne/EDC/PromoMats/CTMS), Salesforce Life Sciences Cloud, Oracle Argus Safety, ArisGlobal, MasterControl, TrackWise, Werum PAS-X, Rockwell PharmaSuite, LabWare, SAP S/4HANA for Life Sciences, Oracle E-Business Suite, SAP ATTP, TraceLink, Sensitech, Controlant across Latin America and the US Hispanic market.

GxP Compliance

How does Vantegrate comply with ANMAT, FDA 21 CFR Part 11, ICH GxP, GAMP 5 and ALCOA+?

Vantegrate inherits the client's compliance posture, delivers the GAMP 5 category 4 validation package (configurable) so your QA team executes the operational validation, and applies ALCOA+ integrity by design across the full GxP framework and regional regulations. Inherited posture: on Salesforce, Life Sciences Cloud (HIPAA, ISO 27001, SOC 1/2, GxP-ready); on Oracle Cloud Infrastructure, OCI and Oracle Health Sciences (including GxP-validated Oracle Argus). The GAMP 5 package includes URS, FS, DS, IQ/OQ/PQ, risk analysis, change control and revalidation. ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, Available). We comply with ANMAT (Disposition 5039/2019 GMP, Disposition 3683/2011 traceability, Law 16,463, Law 25,326, Law 26,529), FDA (21 CFR Part 11, Part 210/211 cGMP, Part 820, DSCSA, HIPAA), EMA, ANVISA (RDC 301/2019, RDC 304, RDC 406/2020), COFEPRIS (NOM-059, NOM-220), INVIMA, ISP Chile, DIGEMID Peru, ICH Q7-Q10, full GxP (GMP, GLP, GCP, GDP, GVP), WHO Prequalification, the EU Falsified Medicines Directive, GS1 Standards (DataMatrix, SNI, GTIN, GLN), GDPR for European clinical data, and the EU AI Act for AI systems in regulated operations.

Platform

Does Vantegrate replace Veeva CRM, Salesforce Life Sciences Cloud, Oracle Argus or our systems?

No. Vantegrate integrates with existing systems via REST API, native connectors or industry standards. CRM: Veeva CRM and Salesforce Life Sciences Cloud (call planning, visit cycle, HCP/HCO target lists, share of voice). Vault: Veeva Vault Safety, Vault QualityOne, Vault EDC, Vault PromoMats, Vault CTMS, Vault Distribution. Pharmacovigilance: Oracle Argus Safety, ArisGlobal LifeSphere. Quality and compliance: MasterControl, TrackWise, Sparta Systems TrackWise Digital. Manufacturing and MES: Werum PAS-X, Siemens Opcenter, Rockwell PharmaSuite. LIMS: LabWare, Thermo Fisher SampleManager, STARLIMS. ERP: SAP S/4HANA for Life Sciences, Oracle E-Business Suite, Microsoft Dynamics 365 for Life Sciences, Infor CloudSuite Industrial. Serialization: SAP ATTP, TraceLink, Systech UniSecure, rfXcel (Antares Vision), Adents. Cold chain: Sensitech (Carrier) TempTale Cloud, Controlant Saga Platform, monnit, ELPRO, Berlinger Smartview, Cryopak. Market data: IQVIA, Komodo Health, Flatiron, Symphony Health. Clinical EDC: Veeva Vault EDC, Medidata Rave, Oracle Health Sciences, Castor, Florence eBinders.

Product

Can Sellium answer technical drug questions without violating pharmaceutical promotion rules?

Yes, as long as the content comes from material approved by medical and regulatory affairs. Sellium works from curated response libraries: any question about indications, dosage or contraindications is answered only from approved technical data sheets; anything not covered is routed to the medical team with a predefined message. The agent doesn't improvise: if it has no approved answer, it says so and routes the question. Promotion of prescription drugs to the general public is restricted by almost every regional health authority (ANMAT, FDA, ANVISA, COFEPRIS, INVIMA, ISP, DIGEMID, EMA). Sellium is used for B2B communication (manufacturer to wholesaler, distributor to pharmacy, manufacturer to hospital), not for promotion aimed at patients. WhatsApp-approved templates and the agent's flows are designed to respect that boundary. For controlled products (psychotropics, narcotics on the ANMAT list I-IV), the agent requires supporting documents (a filed prescription, a purchase order signed by the technical director, a license number) before processing, and blocks automatically if any requirement is missing.

Product

How does Sellium route an adverse event detected on WhatsApp to Argus/Vault Safety while meeting PV deadlines?

The agent detects adverse-event vocabulary (reaction, allergy, discomfort after administration, rash, anaphylaxis, lack of efficacy, sentinel event) and automatically opens a pre-formatted ICSR (Individual Case Safety Report) case in E2B(R3) format, captures minimum data with de-identification (patient initials, age, sex, product lot, administration date, description of the event, severity, outcome) under a data-minimization principle per Law 25,326 / HIPAA / GDPR, codes MedDRA, generates a pre-formatted narrative, and sends the case to Oracle Argus Safety / Veeva Vault Safety / ArisGlobal LifeSphere with an auditable timestamp. It notifies the PV lead in minutes, instead of the days manual entry of a report that came in via WhatsApp, mail or fax can take. Everything is left with an immutable audit trail that satisfies what an ANMAT, ANVISA, COFEPRIS, FDA or EMA inspector will ask for when reviewing a case's lifecycle, including compliance with regulatory deadlines for expedited reports (15 days, 30 days depending on severity).

Product

How does Arconte process hybrid batch records, CoAs and ICSRs with ALCOA+ integrity?

Arconte digitizes the paper component (including handwriting), reconciles it with the MES and delivers pre-reviewed packages, with a confidence score per field and automatic routing to an exceptions queue for human review when it falls below the threshold. All with an immutable audit trail that meets ALCOA+ by design. Hybrid batch records (paper plus Werum PAS-X / Rockwell PharmaSuite): digitizes the paper, reconciles it with the MES and delivers the unified pre-reviewed package for the QP. CoAs from 80-plus API and excipient suppliers in heterogeneous formats: extraction of purity, method-by-method results (HPLC, GC, IR, DSC, KF), validation against spec, OOS/OOT detection and automatic lot blocking in SAP/Oracle upon confirmed OOS. ICSRs from any format (email, PDF, fax, handwritten, medical visit, WhatsApp): classification, extraction with de-identification, MedDRA coding, a pre-formatted narrative and conversion to E2B(R3) ready to upload to Argus/Vault Safety/ArisGlobal in minutes, instead of manual entry. The audit trail logs which document, which algorithm, which model version, what data it extracted, what confidence score, who reviewed the exceptions and when.

Product

How does Revio achieve higher HCP open rates than email and recall execution within the regulatory deadline?

WhatsApp has a structurally higher open rate than email to HCPs because it's the channel where the HCP, pharmacist or wholesaler is already communicating: industry studies put WhatsApp Business open rates between 75% and 98% against the 20-25% real-world rate for email (Bird 2024; Brevo 2026). Revio only fires approved templates and leaves everything with an auditable timestamp. For HCP campaigns it segments by specialty, territory, visit cycle, prescriber profile and more from Veeva CRM or Salesforce LSC, using only Veeva Vault PromoMats templates with 'approved current' status (attempts to send an unapproved template are blocked with an alert to the responsible party). For regulatory recalls: the pre-approved template goes out within a couple of hours (the FDA requires initiating action on a Class I recall within 24 hours, 21 CFR Part 7), pharmacies confirm read and physical withdrawal via WhatsApp with the quantity withdrawn, units dispensed in the last 7 days and the responsible pharmacist; it's left with an auditable timestamp and a record reportable to ANMAT/FDA/ANVISA/COFEPRIS. It complies with ANMAT HCP promotion rules, ANVISA RDC 406/2020, COFEPRIS NOM-220, FDA, the PhRMA code, the WhatsApp Business API with documented pharmaceutical opt-in and immediate, immutable opt-out.

Product

Does Metrix query GxP data from Werum/LabWare/Argus without altering ALCOA+ integrity?

Yes. Metrix is a query layer, not a transformation layer. Data still lives in Werum PAS-X, LabWare, Oracle Argus, Veeva Vault, MasterControl, TrackWise, SAP S/4HANA. Metrix reads, presents and builds the visualization, but never writes or alters the source data, preserving the source system's ALCOA+ integrity by design. The audit trail logs which query each user ran and with what result, without affecting the source system's integrity. For GAMP 5 validation: Vantegrate delivers the package adapted to a validated-data query tool (URS, FS, DS, IQ, OQ, PQ focused on query fidelity and audit trail traceability). Validation complexity is lower than for a transactional system because Metrix is not the source of truth. Semantic layer: business terms (sales, OEE, share of voice, lot, RFT) are translated into single, approved technical definitions so every manager sees the same number. Permissions: Metrix respects the source system's permission model: if a user can't see Brazil's sell-in in Salesforce, they won't be able to ask Metrix for it either.

Product

How does Trazzo monitor 2-8°C and ultra-cold -70°C cold chain with Sensitech and Controlant?

Via API: Sensitech offers the TempTale Cloud API and Controlant has its Saga Platform. Trazzo receives the temperature stream every 1-5 minutes, associates it with the shipment in progress, fires configurable alerts and saves the thermal curve as chain of custody, taking excursion detection from 12-48 hours (datalogger download on return) down to minute zero. Alerts are configurable (for example: 30 consecutive minutes out of range equals a critical alert; a brief excursion during loading/unloading equals a logged event with no alert). For ultra-cold -70°C (mRNA vaccines, cell therapies) it's a distinct operating mode: specific dataloggers (Sensitech UltraFreeze, Controlant Crystal), stricter thresholds, a dry-ice re-icing protocol en route and thermal container validation before departure. If the excursion compromises the product per the manufacturer's QA rules, Trazzo blocks the delivery, triggers the return-to-DC protocol and generates a documented event in TrackWise/MasterControl. The compromised product never reaches the patient. It supports integration with SAP TM, Oracle Transportation Management Cloud, Manhattan Active WMS, Veeva Vault Distribution and Samsara/Geotab telematics.

Product

Does Trazzo support GCP-ready chain of custody for decentralized clinical trial (DCT) kits?

Yes, it's one of the fastest-growing use cases. For sponsors and CROs shipping clinical kits from the investigator site to the patient, or biological samples from the patient to the central lab, Trazzo captures GCP-ready chain of custody: patient identification by study ID (not by name, per the data-minimization principle), patient or caregiver signature captured on site, timestamped geolocation, an auditable report attachable to the CRF in a CTMS (Veeva Vault CTMS, Medidata RTSM). It complies with ICH GCP, FDA 21 CFR Part 11 for electronic records and signatures, and GDPR Article 9 for European clinical data. In a typical scenario, a regional CRO with several investigator sites that today arrives at an FDA audit with deliveries lacking verifiable documentation would move to having every shipment with auditable traceability and a much shorter response time to regulatory audit queries.

Implementation

How long does it take to implement Vantegrate at a mid-sized generics manufacturer, biotech or CRO?

A production pilot of Sellium (one product line, one indirect channel, integration with ERP and CRM) usually takes 6-10 weeks. Expanding to the full portfolio and all channels (wholesalers, retail, hospital, medical visits): 4-6 months. A Revio pilot with one segment (wholesaler communication): 4-8 weeks including WhatsApp Business Platform onboarding, the first approved template and CRM connection. Expanding to regulatory and HCP communication: an additional 6-10 weeks. Arconte for a narrow use case (API invoice matching): 6-10 weeks; critical GxP use cases (batch release, ICSR) with GAMP 5 validation: 12-20 weeks. Metrix's first production use case (conversational BI over commercial and channel data): 6-10 weeks; expanding to GxP data with GAMP 5 validation: an additional 12-20 weeks. Trazzo pilot for one route with one carrier: 4-6 weeks; regional rollout with 1 hub and 50-100 daily deliveries: 8-12 weeks; multi-country LATAM rollout: 4-6 months. GAMP 5 validation runs in parallel with the pilot. We work in short sprints with deliverable value every 2 weeks.

Platform

Does Vantegrate run on Salesforce or on Oracle Cloud Infrastructure? How do I choose?

Each product runs 100% on Salesforce or 100% on Oracle Cloud Infrastructure depending on the manufacturer's stack. The choice is defined by the client's stack, not by our commercial preference. If the client has Salesforce Life Sciences Cloud as its CRM and operating backbone, we deploy Vantegrate 100% Salesforce-native, sharing the HCP/HCO/Account/Activity data model. If they have Veeva CRM on top of Salesforce, we connect via Veeva's standard API. If they have Oracle Cloud Infrastructure and Oracle Transportation Management Cloud / Oracle Health Sciences / Oracle Argus, we deploy Vantegrate 100% OCI-native. Same functional capability, run on two different infrastructures. The compliance posture is inherited from the client: on Salesforce it inherits Life Sciences Cloud (HIPAA, ISO 27001, SOC 1/2, GxP-ready, FedRAMP when applicable); on Oracle Cloud Infrastructure it inherits OCI and Oracle Health Sciences (SOC 1/2, ISO 27001, HIPAA, GxP, GxP-validated Oracle Argus).

GxP Compliance

Does Vantegrate integrate with Veeva Vault PromoMats to use only approved material in campaigns?

Yes. Revio integrates with Veeva Vault PromoMats or with MasterControl. Only templates with 'approved current' status can trigger campaigns; any attempt to send an unapproved template is blocked with an alert to the responsible party. The approval chain is logged and linked to the send. Every Revio send is left with the recipient, phone number, send/delivery/read timestamps and the recipient's response, exportable as compliance evidence for ANMAT, ANVISA, COFEPRIS, INVIMA or FDA. For fair balance and regulatory claims: Vantegrate respects the sector's ethical promotion guidelines and the mandatory data required by regulation (full prescribing information, conditions, issuing entity when applicable). The manufacturer keeps full editorial control: it defines what gets sent, when and to whom. Vantegrate enables compliant communication, logs every interaction and delivers the audit trail; the manufacturer keeps regulatory control of the content and operates the communication policy.

Implementation

Can Vantegrate be used to coordinate patients in decentralized clinical trials (DCT) under GCP?

Yes, within the GCP (Good Clinical Practice) framework and with informed consent specific to digital communication for the patient. It's a typical DCT (Decentralized Clinical Trials) use case: Revio manages dose reminders, virtual monitoring visits, kit shipment; Sellium handles structured inquiries from the enrolled patient with routing to the CRA or sub-investigator when it exceeds parameters; Arconte processes source documents uploaded by sites for reconciliation against the eCRF in Veeva Vault EDC / Medidata Rave / Castor / Oracle Health Sciences with automatic queries (significantly reducing the per-site monitoring backlog); Trazzo orchestrates kit shipments to patients with GCP-ready chain of custody (study ID instead of name, patient or caregiver signature, geolocation plus timestamp, an auditable report attachable to the CRF in a CTMS). Vantegrate works with the sponsor or CRO to align templates and flows with the protocol approved by the ethics committee. It complies with ICH GCP, FDA 21 CFR Part 11, GDPR Article 9 for European clinical data.

ROI

How is the ROI of Vantegrate measured at a manufacturer, biotech, CRO or pharmaceutical distributor?

ROI is measured on three fronts. Incremental revenue: more indirect-channel coverage, better inquiry-to-order conversion, reactivation of dormant wholesalers, and better adoption of new indications by reaching the HCP through a channel that actually gets opened. Operating savings: lower cost-to-serve, faster batch release that frees up the QP, ICSR structured in minutes, and inspection prep down from weeks to hours. And regulatory risk mitigation: routing pharmacovigilance on time and executing the recall on time avoid sanctions, and catching the temperature excursion instantly avoids losing cold chain (IATA estimates USD 2.5-12.5 billion per year, up to USD 35 billion according to AJHP 2023). As a reference, McKinsey reports that digitizing quality control in pharma can add 30-40% productivity and cut QC costs by more than 50%. Payback by case, depending on baseline: Sellium 4-9 months, Revio 3-6, Arconte 6-12, Metrix 4-9, Trazzo 6-12.

Each AI agent applied to the pharmaceutical industry is part of a broader suite with a unified GAMP 5 validation package and ALCOA+ compliance. Get to know each product in detail, the technology it runs on and how to engage us.

Products

Explore each agent in depth: Sellium for B2B order taking with adverse event routing to Argus in E2B(R3), Revio for mass HCP campaigns with Veeva Vault PromoMats templates and regulatory recall with documented confirmation within the deadline, Arconte for IDP of batch records, CoAs, ICSRs and FDA Form 483 with GAMP 5 and ALCOA+, Metrix for conversational BI over OEE, RFT, batch yield and IQVIA market share without altering the source system's ALCOA+ integrity, and Trazzo for pharmaceutical last mile with 2-8°C and ultra-cold -70°C cold chain monitored live with Sensitech and Controlant.

Technology

Vantegrate integrates with the standard pharmaceutical stack: Salesforce Life Sciences Cloud and Marketing Cloud, Oracle Health Sciences, Argus Safety and Cloud Infrastructure, Veeva CRM/Vault Safety/QualityOne/EDC/PromoMats/CTMS, MasterControl, TrackWise, Werum PAS-X, LabWare, SAP S/4HANA for Life Sciences, SAP ATTP, TraceLink, Sensitech, Controlant, IQVIA, Komodo Health, Flatiron. It meets the security and compliance standards (SOC 2 Type II, ISO 27001, GxP-ready, ANMAT, FDA 21 CFR Part 11, ICH Q7-Q10, GAMP 5, EMA, WHO PQ, EU FMD, DSCSA, GS1 Standards, ALCOA+) a pharmaceutical operation requires.

Company

Behind the suite is a premium implementation team focused on Big Pharma, biotech, generics manufacturers, OTC manufacturers, vaccine producers, CROs and sponsors, pharmaceutical distributors, wholesalers, medical device manufacturers and mid-sized to large CMO/CDMO operators, with native GxP compliance. Learn more about Vantegrate and review the available engagement models.

Más de 35 integraciones directas

SalesforceMercado PagoOpenpayPaywayOracleServiceNowSlackSAPStripeFiservSalesforce Marketing CloudMicrosoft Dynamics 365HubSpotWhatsApp BusinessSalesforceMercado PagoOpenpayPaywayOracleServiceNowSlackSAPStripeFiservSalesforce Marketing CloudMicrosoft Dynamics 365HubSpotWhatsApp Business

How many sales slipped away while you read this?

Every minute a WhatsApp message goes unanswered is an opportunity moving to your competitor. Book a demo and find out how much Sellium can sell for your company.

Book a demo
Team at the office at sunset
Team in an office hallway
Team working on laptops
Team working by the docks
Team in a boardroom
Team working with a river view
Salesforce
ISV Partner
AppExchange Partner
Salesforce · Since 2009
Oracle
OCI Partner
Marketplace & OCI Partner
Oracle Cloud Infrastructure