Regulatory clarity, powered by evidence.

FDA regulations are vast, interconnected, and unforgiving of mistakes. Finding the right section of 21 CFR — and understanding how it connects to guidance documents, authorizing statutes, device classifications, drug approvals, and related requirements — can take hours of manual research.

Compliome was built to change that. We combine a knowledge graph of more than 1.2 million regulatory data points — the full 21 CFR and FDA guidance, plus device clearances, drug approvals, drug pharmacology and mechanism data, recalls, warning letters, and clinical trials, and international coverage from the EMA (EU), MHRA (UK), Health Canada, Swissmedic (CH), EU clinical trials, EU legislation, and ICH guidelines — with modern AI retrieval to deliver answers that are fast, cited, and verifiable. Every response points back to its source, so you can trust what you read and show your work.

What makes us different

• Grounded, not generative guesswork. Answers are retrieved from real regulatory text and FDA data, with citations you can follow.
• Connected understanding. Our knowledge graph maps cross-references, statutes, product categories, semantic topics, device classifications, drug approvals, drug targets and pathways, enforcement actions, clinical trials, and international authorities (EMA, MHRA, Health Canada, Swissmedic, plus EU legislation and ICH).
• Built for professionals. Designed for regulatory affairs, quality, and consulting teams who are accountable for accuracy.

Important note

Compliome is an informational research tool. It does not provide legal or regulatory advice, and it is not a substitute for professional judgment or counsel.