AI-powered intelligence on FDA inspections and investigators.
FDA Intel is the leading provider of AI-powered insights into FDA inspections and investigator intelligence, for drug developers and the stakeholders around them.
Our mission
Help the teams who answer to FDA see what FDA sees, early enough to act: before an inspection, a supplier decision or a deal.
What we built
Three layers, each feeding the next.
- 1The libraryOne of the largest libraries of FDA inspection documents anywhere: Form 483s, inspection reports, warning letters, close-outs and responses.
- 2Structured dataEvery document parsed and extracted, then organized by site, investigator, regulation, observation topic, product sector and classification.
- 3AI-native workflowsProprietary workflows that connect each site's history and turn it into answers, profiles and reports.
What we deliver
Inspection and investigator intelligence
Site histories, FDA investigator profiles, citation trends and observation topics, for any FDA-inspected site.
Investigator profilesCustom reports by our team
Everything we hold about your site, investigator and the regulations that matter, parsed and analysed for you.
Custom reportsDocuments
The original Form 483s, inspection reports, warning letters and responses, priced per document.
Search documentsAI connector
The same structured data inside Claude, ChatGPT and other AI tools, by monthly plan, with a REST API for your own systems.
See the AI connectorUsed for inspection readiness, due diligence, supplier vetting and competitive intelligence.
Built for the people who answer to FDA.
- Drug and biologics developers (quality, regulatory and manufacturing)
- Medical device makers
- CDMOs and CMOs
- Supplier-quality teams
- Consultants
- Investors and analysts (due diligence)
- Law firms
How we work
- IndependentNot affiliated with or endorsed by the U.S. Food and Drug Administration.
- Data, not adviceWe deliver insights, data and documents; we do not give legal, regulatory or investment advice.
- Facts firstEvery insight traces back to the FDA document it came from, and every price is shown before you pay.
Get in touch
Questions about intelligence, a report, an order or your team's needs? Write to info@fdaintel.ai or use the contact page.
FDA Intel is a product by Cortex Group.