Pharmacovigilance monitoring[→]
Autonomous agents that monitor adverse event signals across literature, social media, and regulatory databases. Signal detection, triage, and case filing preparation.
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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.
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
GxP and FDA requirements
01
01
21 CFR Part 11
Electronic records and signatures — the foundation of GxP compliance for AI
02
02
FDA AI/ML Guidance
Evolving FDA framework for AI/ML in drug development and medical devices
03
03
GxP Validation
Process validation requirements for AI in GMP/GCP/GLP environments
04
04
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
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
Book a life sciences AI conversation — validation and compliance from architecture to submission.
contact@proticom.com
844.PROTICOM
proticom.ai
844.PROTICOM
proticom.ai