AI for Pharma & Life Sciences: GxP Validated, Audit-Ready AI
From clinical evidence to HCP compliance, we build AI that meets pharma's regulatory requirements from day one.
What we see in the field.
GxP validation slows AI adoption
IQ/OQ/PQ, 21 CFR Part 11, full audit trails. Most AI vendors have never been through pharma validation. The gap between what they promise and what passes QA is enormous.
HCP engagement compliance is manual and slow
Every communication needs review. Teams spend more time on compliance than engagement. The review bottleneck limits how fast your field teams can operate.
Clinical evidence volumes overwhelm manual processes
Thousands of new publications monthly. Teams can't read everything but are responsible for knowing everything. Manual literature review doesn't scale.
Pharmacovigilance can't keep up
AE reports from trials, spontaneous reports, literature, social media growing exponentially. Signal detection at the speed and scale required is beyond manual capability.
Solutions we build in two weeks.
Pharma & Life Sciences AI
HCP engagement, clinical evidence automation, pharmacovigilance, and regulatory intelligence. All GxP validated.
Learn more →Enterprise RAG Systems
Regulatory document search across ICH, FDA, EMA guidelines, and internal submission histories with full citations.
Learn more →Compliance & Risk Agents
GxP monitoring, 21 CFR Part 11 verification, and automated regulatory change management.
Learn more →Real-world applications.
Adverse event case triage
Pharmacovigilance intake runs around 30 hours a week for a mid-size portfolio: inbox triage, free-text classification, Argus fields re-keyed from call-center transcripts. We build the agent that triages and structures the cases. Built in two weeks, in your validated environment.
Medical information request responses
Your team writes the same set of medical information letters every month: the product, the indication, the citation set, the reviewer cycles. We build the agent that drafts them to your standard against a real inbox. Built in two weeks.
We built Bayer an AI compliance scanner for marketing assets, checked against Dutch and EU health-claims regulations. 620+ assets scanned, 11 rules per scan, traffic-light verdicts with source citations. Review dropped from two to three hours of manual work to about two minutes per asset.
Read engagement note →From workflow to working tool in two weeks.
Scope and sign
We define the workflow, the deliverables, and the acceptance criteria, and sign an agreement on them before anything starts.
Build
We build the tool in your environment, with Claude Code and automated evaluation against your own data.
Pay when it works
$10,000, due only after every criterion in the signed agreement is met. Nothing before that.
Questions buyers ask.
How do you handle GxP validation for AI systems?
We follow full IQ/OQ/PQ validation protocols with complete documentation for every AI system. Our implementations are built with 21 CFR Part 11 compliance from the architecture level, including electronic signatures, audit trails, and role-based access controls.
Can the AI integrate with our existing pharma systems?
Yes. We integrate with Veeva Vault, IQVIA, Medidata, SAP for Life Sciences, and other pharma-specific platforms. The AI reads from your systems of record without modifying validated data.
How does the AI handle adverse event detection across data sources?
Our pharmacovigilance AI monitors clinical trial databases, spontaneous reporting systems, published literature, and real-world evidence simultaneously. It uses NLP to identify potential safety signals across structured and unstructured sources, then routes findings to safety teams for medical review.
Is the system compliant with both FDA and EMA requirements?
Yes. We build AI systems that meet both FDA and EMA regulatory requirements simultaneously, including 21 CFR Part 11, EU MDR, GDPR data residency, and ICH guidelines. Multi-region pharma companies can run a single compliant system.
What is the typical timeline for deploying pharma AI?
We scope one workflow with you and sign the acceptance criteria, then build the tool in two weeks. For GxP-validated systems we include the IQ/OQ/PQ documentation the workflow requires. Larger programs run as a sequence of two-week builds, one workflow at a time.
Ready to ship AI that actually works?
Send us the workflow. We return a fixed scope, price, and acceptance criteria in 48 hours. You pay $10,000 only after it works.
Tell us the workflow →