Cited, evidence-based answers
Every response is grounded in 21 CFR sections and FDA guidance, with inline citations you can verify and follow to the source.
FDA Regulatory Intelligence
CFR21 is an AI research assistant that answers your questions about 21 CFR and FDA guidance — with citations, evidence, and interactive visualizations from a knowledge graph of 80,000+ regulatory sources.
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Capabilities
Not a generic chatbot. CFR21 is purpose-built for FDA regulatory work, with answers you can verify down to the section.
Every response is grounded in 21 CFR sections and FDA guidance, with inline citations you can verify and follow to the source.
See how regulations, guidance, and product categories connect. Explore cross-references in a force-directed visualization.
BM25 keyword matching fused with vector similarity surfaces the most relevant passages — not just keyword hits.
An automated ingestion pipeline tracks new and updated FDA guidance and eCFR regulations as they are published.
Approval roadmaps, submission checklists, comparison tables, and timelines — generated from your questions.
Designed for regulatory affairs, quality, and consulting teams who need answers they can stand behind.
How it works
Pose any question about FDA regulations, submission pathways, or compliance requirements.
CFR21 searches a knowledge graph of 80,000+ regulatory nodes using hybrid semantic retrieval.
Receive an evidence-based response with citations and interactive visualizations you can trust.
Knowledge graph
Regulations don't exist in isolation. CFR21 maps cross-references, authorizing statutes, product categories, and semantic topics — so you understand not just the rule, but everything it touches.
Explore the graphJoin regulatory professionals using CFR21 to research faster and cite with confidence.