AI for pharma that ships through validation not around it.
We embed engineers inside pharma manufacturers, CROs, clinical teams, and medical-affairs functions for 4 weeks walk GxP floors, read protocols, shadow monitors, audit validation artefacts. Then we ship GxP-compliant, 21 CFR Part 11-aligned AI every month. 44% reduction in protocol-deviation review time is not a slide it is what a mid-cap pharma team measured in 120 days.
faster protocol-deviation review
faster CSR section drafting
lift in MR visit-to-prescription conversion
Why AI projects in pharma fail the validation gate
The model has no CSV / GxP validation plan
Computer System Validation, 21 CFR Part 11 audit-trail, and electronic-signature integrity were ignored in the pilot. Quality shuts it down before production.
Training data leaks patient identifiers
Even pseudonymised data has quasi-identifiers. Without a formal data-protection impact assessment, DPDPA and GDPR exposure kills the project.
Medical affairs was not in the loop
Commercial-driven AI proposals get stopped by medical for good reason promotional-only optimisation is non-compliant. Medical must co-own the initiative.
CRO tech stack was assumed to be cooperative
Real-world CRO systems have 14-day data-lag and closed APIs. Monitoring AI built on yesterday's data is not risk-based, just slow.
Every metric is a problem we solved.
Real numbers from live pharma & life-sciences deployments.
Protocol deviations found at quarterly review
CSR drafts stay on the critical path
MR visit logs never feed insight
GMP deviations take weeks to become CAPAs
What your team actually says.
"PV volume is up 40%. Headcount is flat. Regulatory clocks are not."
PV Head
"Deviations are found at quarterly reviews. Too late."
Clinical Operations
"CSRs are always the critical path before filing."
Medical Writing Lead
"MR effort data exists. Insight doesn't."
Commercial Excellence
"GMP deviations take weeks to become CAPAs."
QA Head
"Regulatory updates get missed across 30 markets."
RA Head
Use cases that move the needle.
01Pharmacovigilance ICSR Narrative Drafting
AI structures intake and drafts MedDRA-coded narratives from raw reports.
02Risk-Based Clinical Monitoring
Data-driven triaging of sites and subjects for targeted SDV and remote monitoring.
03Medical Writing Assistant
Generates draft CSR sections, IBs, and briefing documents from trial data and SAP.
04MR / Field Force Next-Best-Action
Analyses visit logs, CRM, and (consented) Rx data to drive per-MR recommendations.
05Regulatory Intelligence Agent
Monitors global regulatory updates and maps them to your products, trials, and registrations.
06GMP Deviation Triage
LLM reads deviation records, classifies criticality, drafts CAPA recommendations.
Four pillars. Translated for Pharma.
An Engineer Inside Your Validated Environment
Our Forward Deployed Engineer sits with safety, clinical ops, medical writing, and QA. They understand your CSV framework, deviation process, and why the electronic signature on CAPA #24 matters.
GxP-Grade R&D
Our Research Engineers run 2-week sprints on compliant architectures audit trails, role-based access, validation artefacts, signed deterministic outputs so the model ships through quality, not around it.
A Working Release Every 30 Days
Mid-month qualification runs in your validated environment. End-of-month release with signed IQ/OQ/PQ, risk assessments, and SOP updates. No pilot-to-production chasm.
We Own the Timeline & Compliance Number
We don't bill hours. Every month you get delta on PV throughput, deviation-review TAT, CSR section TAT, MR conversion, and regulatory miss-rate. If the numbers aren't moving, you'll know.
What happens in the first 30 days.
Function Walk & Data Inventory
Our engineer shadows PV, clinical ops, medical writing, MR, and QA. Maps EDC, PV systems, CTMS, CDMS, eTMF, and commercial CRM.
GxP & Validation Mapping
21 CFR Part 11, CSV, GAMP 5, DPDPA / GDPR obligations translated into architecture constraints. Validation artefact templates prepared.
AI Opportunity Scoring & Mockups
Each opportunity scored by compliance feasibility, timeline impact, and data readiness. Mockups validated with medical, QA, and commercial.
Strategy Deck & Roadmap Delivery
12-month AI roadmap, cost-benefit case, validation plan, and integration architecture handed over. Yours to keep.
What you walk away with
We speak your regulatory language.
Regulations & Certifications
- 21 CFR Part 11 — Electronic records and signatures (US FDA)
- GxP — GCP / GMP / GLP / GDP umbrella
- GAMP 5 — Risk-based approach to computerised system validation
- GDPR — EU data protection for clinical data
- DPDPA 2023 — Indian data protection
- Schedule M (India) — GMP for Indian manufacturers
Data & Protocol Standards
- CDISC SDTM / ADaM
- HL7 / FHIR
- MedDRA
- WHODrug
- E2B(R3) for PV
- XEVMPD
Enterprise Systems We Integrate
- EDC Medidata Rave, Oracle Clinical, Veeva Vault EDC
- CTMS Veeva Vault CTMS, Oracle Siebel CTMS
- PV Oracle Argus, ARISg, Veeva Vault Safety
- eTMF Veeva Vault eTMF
- MR CRM Veeva CRM, IQVIA OCE
- MES / QMS Werum PAS-X, TrackWise, MasterControl
Questions we hear on the shop floor.
Book the 4-Week Pharma Audit
21 CFR Part 11 · GxP · GDPR · DPDPA aware. Validation-ready.
The first step is always a conversation.