FDA Regulatory Intelligence

Navigate FDA regulations with confidence.

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.

14-day free trial · No credit card to explore · Cancel anytime

80,000+
Regulatory nodes
21 CFR
Full title coverage
2,200+
FDA guidance docs

Capabilities

Regulatory research, grounded in evidence.

Not a generic chatbot. CFR21 is purpose-built for FDA regulatory work, with answers you can verify down to the section.

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.

Interactive knowledge graph

See how regulations, guidance, and product categories connect. Explore cross-references in a force-directed visualization.

Hybrid semantic search

BM25 keyword matching fused with vector similarity surfaces the most relevant passages — not just keyword hits.

Always current

An automated ingestion pipeline tracks new and updated FDA guidance and eCFR regulations as they are published.

Rich visual outputs

Approval roadmaps, submission checklists, comparison tables, and timelines — generated from your questions.

Built for professionals

Designed for regulatory affairs, quality, and consulting teams who need answers they can stand behind.

How it works

From question to cited answer in seconds.

01

Ask in plain English

Pose any question about FDA regulations, submission pathways, or compliance requirements.

02

We query the graph

CFR21 searches a knowledge graph of 80,000+ regulatory nodes using hybrid semantic retrieval.

03

Get a cited answer

Receive an evidence-based response with citations and interactive visualizations you can trust.

Knowledge graph

See the connections others miss.

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 graph

Start your 14-day free trial.

Join regulatory professionals using CFR21 to research faster and cite with confidence.