AI built for pharma — GxP validated, audit-ready, 21 CFR Part 11 compliant
HCP engagement compliance, clinical evidence automation, adverse event monitoring, and regulatory document intelligence. Every system validated: IQ/OQ/PQ.
Pharma compliance makes AI uniquely hard.
GxP validation slows AI adoption
IQ/OQ/PQ, 21 CFR Part 11, full audit trails. Most AI vendors have never been through pharma validation.
HCP engagement compliance is manual and slow
Every communication needs review. Teams spend more time on compliance than engagement.
Clinical evidence volumes overwhelm manual processes
Thousands of new publications monthly. Teams can't read everything but are responsible for knowing everything.
Pharmacovigilance can't keep up
AE reports from trials, spontaneous reports, literature, social media. Growing exponentially.
Use Cases
Built for pharma's unique challenges
HCP Engagement Compliance
AI content review against FDA regulations and industry codes.
Clinical Evidence Automation
Literature monitoring, evidence synthesis, systematic review acceleration.
Regulatory Document Intelligence
Search across submission histories, FDA guidance, EMA guidelines, ICH standards.
Pharmacovigilance & Safety
AE detection across case reports, clinical trials, real-world evidence.
Medical Information Management
AI-powered MI query response grounded in approved content.
Sample Management & Compliance
Automated tracking and compliance monitoring for HCP samples.
Compliance frameworks
GxP Validation
Full IQ/OQ/PQ protocols. Complete validation documentation for every AI system.
21 CFR Part 11
Electronic records and signatures, audit trails, access controls. Built into the architecture.
GDPR Compliance
Data residency, consent management, right-to-erasure for European operations.
EU MDR
Medical device regulation compliance for AI systems in the EU market.
ICH Guidelines
Full alignment with ICH standards across all AI implementations.
SOC 2 Type II
Third-party verified security controls and operational practices.
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.
Based on use case scope, data volumes, and validation requirements. Start with a Pharma AI Assessment.
Tell us the workflow →Questions buyers ask.
How do you handle GxP validation for AI systems?
We follow full IQ/OQ/PQ validation protocols with complete documentation. Every AI system is built with 21 CFR Part 11 compliance from day one — including electronic signatures, audit trails, and access controls required for pharma regulatory submissions.
Can the AI system be used for HCP engagement compliance?
Yes. Our AI reviews HCP communications against FDA regulations, industry codes, and your internal policies. It flags compliance risks before content goes out, reducing manual review cycles from days to hours.
How does the pharmacovigilance AI handle adverse event detection?
The system monitors clinical trial data, spontaneous reports, published literature, and real-world evidence for adverse events. It uses NLP to identify potential safety signals across structured and unstructured data sources, then routes findings to safety teams for review.
What data sources can the clinical evidence automation connect to?
We connect to PubMed, ClinicalTrials.gov, Embase, Cochrane, FDA databases, EMA resources, and your internal clinical data repositories. The system monitors new publications and flags relevant evidence automatically.
Is the AI system compliant with EU MDR and GDPR?
Yes. We build AI systems with EU MDR compliance for medical device-related use cases and full GDPR compliance including data residency, consent management, and right-to-erasure for European operations. Data processing agreements and DPIAs are included.
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 →