Every authority, one engine
21 CFR, EU legislation, Swissmedic, and a growing list of global authorities, cited down to the section.
How does an EU MDR requirement compare to its US equivalent?
Global Regulatory Intelligence
Every regulation. Every jurisdiction. One knowledge engine.
Compliome is an AI research assistant that answers your questions across 21 CFR, FDA guidance, EU legislation, device clearances, drug approvals and pharmacology, and clinical trials, spanning the US, EU, UK, Canada, and Switzerland. Every answer comes with citations, evidence, and interactive visualizations from a knowledge engine of 1.2M+ data points.
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1.2M+
Knowledge points
4
Connected domains
US · EU · UK · CA · CH
Jurisdictions live today
Growing
New authorities added continuously
The four pillars
Not just the rules. Everything the rules touch, everywhere they apply.
Compliome connects regulatory text, medical science, competitive intelligence, and (soon) literature in one engine with the same cited, evidence-based answers across every domain.
Drugs, targets & pathways
Pharmacology, mechanisms, disease and repurposing signal.
What's the MOA behind this drug class?
Orgs, trials & enforcement
Competitive and compliance signal across sponsors and authorities worldwide.
Which sponsors are active in this indication, in the US and the EU?
Published research
The next layer: peer-reviewed literature grounding, linked into the same engine.
What does the literature say about this pathway?
Ask it yourself
Questions that need the whole record, not one document.
Real questions from regulatory work, answered from FDA's own records with a citation for every claim.
Warning-letter citations
Which 21 CFR sections are most frequently cited in FDA warning letters issued by CDER to drug manufacturers?
A ranked list of the CFR sections behind CDER warning letters, linked to the regulation text and example letters.
510(k) predicate chains
Trace the 510(k) predicate chain for K192499: what did it claim equivalence to, and which later submissions relied on it?
The devices a clearance claimed equivalence to and the later 510(k)s that named it as a predicate, each linked to its FDA record.
Complete Response Letters
What are the most common deficiencies FDA cites in Complete Response Letters related to manufacturing facility inspections or CMC?
Recurring facility and CMC deficiency themes drawn from published Complete Response Letters, each tied back to the letters it comes from.
Form 483 observations
Which 21 CFR Part 211 sections are cited most often on FDA Form 483 inspection observations? Give the top five with counts.
The Part 211 sections most often cited in FDA inspectional observations, with counts from FDA Data Dashboard records and links to the regulation text.
How it works
From question to cited answer in seconds.
01
Ask in plain English
Pose any question about regulatory pathways, predicate devices, drug precedent, pharmacology, or compliance requirements, in any jurisdiction we cover.
02
We query the engine
Compliome searches a knowledge engine of 1.2M+ regulatory and scientific data points using hybrid semantic retrieval.
03
Get a cited answer
Receive an evidence-based response with sources and interactive visualizations you can trust.
Why Compliome
See the connections others miss.
Most regulatory tools search one corpus at a time, or give you an answer you cannot verify. Compliome is built for the work that actually happens: comparing authorities, citing primary sources, and following how a rule connects to the science and sponsors behind it.
Explore the engineJoin the Compliome beta.
Join regulatory, scientific, and intelligence professionals using Compliome to research faster and cite with confidence.