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
Navigate FDA regulations with confidence.
Compliome is an AI research assistant that answers your questions about 21 CFR, FDA guidance, device clearances, drug approvals, and clinical trials — with citations, evidence, and interactive visualizations from a knowledge graph of 1.2M+ regulatory data points.
Free during the private beta · Invite required
1.2M+
Regulatory data points
3M+
Mapped connections
21 CFR
Full Title 21 coverage
Capabilities
Regulatory research, grounded in evidence.
Not a generic chatbot. Compliome is purpose-built for FDA regulatory work, with answers you can verify down to the section.
The whole FDA picture — and beyond
Beyond the regulations: device classifications and 510(k)/PMA clearances, drug approvals with Orange Book patents, FDA-label pharmacology (mechanism, PK/ADME, interactions), drug targets, pathways and repurposing leads, recalls and warning letters, clinical trials, and substances — plus international coverage from the EMA (EU), MHRA (UK), Health Canada, Swissmedic (CH), EU clinical trials, EU legislation (EUR-Lex), and ICH guidelines — all linked to the authorities and rules that govern them.
Interactive knowledge graph
See how regulations, guidance, devices, drugs, trials, and enforcement 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.
How it works
From question to cited answer in seconds.
01
Ask in plain English
Pose any question about FDA regulations, submission pathways, predicate devices, drug precedent, or compliance requirements.
02
We query the graph
Compliome searches a knowledge graph of 1.2M+ regulatory data points 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. Compliome maps cross-references, authorizing statutes, product categories, semantic topics, device classifications, drug approvals, drug targets, mechanisms and pathways, enforcement actions, clinical trials, and international authorities (EMA, MHRA, Health Canada, Swissmedic, plus EU legislation and ICH) — so you understand not just the rule, but everything it touches.
Explore the graphJoin the Compliome private beta.
Join regulatory professionals using Compliome to research faster and cite with confidence.