INDUSTRY — LIFE SCIENCES

Life Sciences AI

Pharma and biotech operate in the same regulatory neighborhood as our 15-year healthcare IT practice. GxP, 21 CFR Part 11, and FDA AI guidance aren't new territory for us.

Illustration for life sciences AI

THE CONTEXT

Regulated AI in life sciences

In life sciences, every AI system touches a validation requirement. From GxP-qualified infrastructure to FDA submission documentation, the compliance architecture isn't a layer you add later — it's the foundation you design from. Our work in adjacent regulated environments means we build that way by default.

REGULATORY FRAMEWORK
21 CFR Part 11

Electronic records and signatures — the foundation of GxP compliance for AI

FDA AI/ML Guidance

Evolving FDA framework for AI/ML in drug development and medical devices

GxP Validation

Process validation requirements for AI in GMP/GCP/GLP environments

EU MDR / IVDR

European Medical Device and In Vitro Diagnostic regulations for AI-enabled devices

VALIDATED AI

Where AI creates value in life sciences

AGENTIC AUTOMATION
Pharmacovigilance monitoring

Autonomous agents that monitor adverse event signals across literature, social media, and regulatory databases. Signal detection, triage, and case filing preparation.

AGENTIC AUTOMATION
Regulatory submission agents

Automation of regulatory submission preparation workflows — IND, NDA, 510(k). Document compilation, gap analysis, and review facilitation.

LLM INTEGRATION
Literature review and synthesis

RAG architectures for scientific literature — PubMed, clinical trial registries, internal research. Systematic review support, evidence synthesis, and competitive intelligence.

LLM INTEGRATION
Clinical trial data intelligence

AI-assisted analysis of clinical trial data, protocol deviation detection, and patient population insights. Always within the GxP validation framework.

AI SECURITY & GOVERNANCE
GxP validation and FDA compliance

21 CFR Part 11 compliance for AI systems handling electronic records. GxP validation frameworks. FDA AI/ML guidance alignment. The documentation that makes AI defensible in regulatory submissions.

AI QA & TESTING
Regulated AI validation

Validation of AI systems in regulated research and clinical contexts. Evaluation harnesses, adversarial testing, and the documentation trail that GxP environments require.

FIRST CONVERSATION

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AI GOVERNANCE