Regulatory intelligence pharma teams can check at the source
Get the regulatory intelligence pharma teams need in one cited answer, in seconds.
Ask about warning letters, patents or approvals instead of searching each database. Free to try.
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Ask about FDA warning letters, Orange Book patents, EMA authorisations or shortages across markets. Every claim links to the source document, and the research trail is on the page. Use quick answers for everyday lookups or deep research for harder questions.
Ask the FDA warning letters database question, get the pattern
A QA lead searching the FDA warning letters database wants to know what FDA is citing. Opening each letter to build a benchmark takes too long.
On 4 October 2026, a question about that year's CGMP letters to drug manufacturers returned 29 letters from January to September. The answer grouped the findings:
- Component testing under 21 CFR 211.84, including talc not tested for asbestos.
- Sterile and aseptic failures under 211.113(b).
- Weak investigations under 211.192.
- Quality unit and data integrity gaps under 211.22 and 211.194.
Each letter links to fda.gov. Take the pattern into your site review and open a letter when you need the detail.
FDA Orange Book database: patents, exclusivities and generics
Ask which patents and exclusivities cover apixaban (Eliquis), when they expire, and which generics are approved.
The 4 October 2026 answer drew from the FDA Orange Book database, with 30 citations to FDA entries:
| Patent | Listed expiry | With pediatric extension |
|---|---|---|
| US 6,967,208 | 21 Nov 2026 | 21 May 2027 |
| US 9,326,945 | 24 Feb 2031 | 24 Aug 2031 |
It also listed 13 approved ANDAs with marketing status and therapeutic equivalence codes. Accord and Regcon were listed as active Rx with an AB rating. Each row opens its Orange Book entry.
FDA drug approval database questions and EMA authorisations
Ask when FDA first approved semaglutide. This answer, run on 4 October 2026, gives 5 December 2017, Ozempic, NDA 209637. It also lists Rybelsus, Wegovy and Wegovy tablets, with approval dates and NDA numbers cited to FDA records.
For the EU, the tirzepatide answer cites Mounjaro's EPAR summary. It gives authorisation on 15 September 2022, marketing authorisation holder Eli Lilly Nederland B.V., and the latest Commission decision on 25 June 2026. It also finds the PRAC aspiration signal behind a product-information update in July 2024.
Pharma regulatory intelligence across national registers
One shortage question can compare markets. The 4 October 2026 amoxicillin answer checked FDA, EMA, the UK NHSBSA SSP register and BfArM. It returned a four-row table, each row linked to its source:
- One open BfArM report for an ALIUD powder for oral suspension.
- An EMA notice marked resolved.
- No FDA shortage record found.
- No current UK Serious Shortage Protocol.
Check the pharma coverage list for national registers, including MHRA, ANSM, AIFA, Swissmedic, PMDA and Health Canada. Ask in your language and get the answer in that language.
Pharmaceutical regulatory intelligence that starts free
| Research step | RegAffairs AI | Searching individual FDA or EMA databases |
|---|---|---|
| Get an answer | Cited answer to your question | Records to read and piece together |
| Compare markets | FDA, EMA and national registers in one question | Separate database searches |
| Check the evidence | Source links on every claim, research trail on the page | Assemble the supporting records yourself |
| Time to answer | Seconds, or deep research | Search and review each result |
Bring the question already on your desk:
- RA teams: authorisation status.
- Quality and CMC teams: CGMP findings.
- Generics teams: patents and exclusivities.
- Supply teams: shortages across markets.
- Consultancies: a cited first pass on client research.
FAQ
Can I search FDA warning letters by asking a question?
Yes. Ask about a year, firm, site or CGMP section. The answer summarises the findings and links every letter on fda.gov.
What can I ask about the Orange Book?
Patents, expiry dates, pediatric extensions, exclusivity codes or approved generics. Marketing status and therapeutic equivalence codes come with links to FDA entries.
How much does it cost?
Free to try, no credit card. Pro is $100 per user per month: unlimited questions and deep research, cancel anytime. Enterprise seats, SSO and procurement are available on request.
Is my data used to train models?
No. Questions and uploads are never used for training. Data is processed and stored in the EU by default. See security details.
Ask your first pharma question
Pick the warning letter, patent or shortage you were about to look up by hand. Get the answer with its sources.
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