Decision-centric AI governance framework for biopharma/biotech development. Ten-question independent study on FDA reconstructability, AI accountability, and schema-validated decision logs.
A minimalist and professional landing page for regulatory affairs and formulation training services.
A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.
This is my profile
Python toolkit for generating FDA/IEC-compliant SaMD validation packages — IQ/OQ/PQ protocols, ISO 14971 risk management, IEC 62304 lifecycle, SBOM, and cybersecurity checklists.
RAG-powered AI assistant for querying FDA guidance documents and regulatory intelligence — with source citations, hallucination controls, and a governance framework for regulated life sciences deployment.
AI-powered Regulatory Intelligence for Medical Devices. RAG pipeline with semantic reranking across EU MDR, MPDG, MepV, UK MDR, and more.
RAPath Global Hub - Medical Device Regulatory Reference in Plain English. Properly sourced.
MNC-style pharmaceutical pipeline asset assessment Agent Skill
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