Pharma regulatory intelligence software, cited to the source
RegAffairs AI is pharma regulatory intelligence software. Ask where a medicine is approved, reimbursed or short, and get a cited answer across markets in seconds.
No more piecing together approval registers, reimbursement lists and shortage notices. Free to try.
Try it free. No credit card or demo call.
A portfolio across several markets means records in different languages, on different timelines. Ask about approvals, reimbursement, shortages or safety signals. Every claim links to its official source, and the research trail is on the page.
Who uses pharma regulatory intelligence software?
- Regulatory affairs: check authorisation status before a submission or variation.
- Market access and pricing: compare NICE appraisals, AIFA class A listings and national reimbursement positions.
- Supply chain and medical information: research shortage exposure across a portfolio.
- Safety and labelling: follow PRAC signals and resulting product-information updates.
- Generics strategy: find approval holders and generic approval dates by market.
- Regulatory consultancies: repeat cited lookups across client products.
Name your product, your markets and the details you need: holders, approval dates or reimbursement conditions.
Pharma regulatory intelligence software for multi-market checks
"Is apixaban approved in Switzerland, Japan and Canada?" Our 4 October 2026 check returned one cited table from Swissmedic, PMDA and Health Canada.
| Market | Approval record | Key detail |
|---|---|---|
| Switzerland | Eliquis, 26 Aug 2011 | Authorisation no. 61549 |
| Japan | Eliquis Tablets, 25 Dec 2012 | VTE treatment indication added 21 Dec 2015 |
| Canada | Bristol-Myers Squibb Canada, NOC 16 Dec 2011 | DINs 02377233 and 02397714 |
Open the answer to see the source behind each finding. For a launch or variation check, you read the market positions together, not in a spreadsheet of separate searches.
Pharma regulatory compliance across price, supply and safety
Approval status is the starting point. Pharma regulatory compliance research also means checking reimbursement conditions, shortage reports and safety updates.
Reimbursement and HTA
Compare tirzepatide in England and Italy. NICE TA924 and TA1026 recommend Mounjaro with restrictions for type 2 diabetes and overweight or obesity, respectively. Italy's AIFA list dated 31 May 2026 places all six Mounjaro KwikPen packs in class A, prescribed under Nota 100.
Shortage exposure
Check amoxicillin across FDA, EMA, UK serious shortage protocols and BfArM. The 4 October 2026 answer found an open BfArM report for ALIUD PHARMA powder for oral suspension and a resolved EMA shortage.
Authorisation and safety signals
Review Mounjaro's EU authorisation and safety updates. The answer cites authorisation EMEA/H/C/005620, Eli Lilly Nederland B.V., and a PRAC aspiration signal behind a product-information update in July 2024.
For US portfolio research, explore Eliquis Orange Book patents and exclusivities or FDA CGMP warning letters.
Pharma regulatory software: an answer, not another search
| Research task | RegAffairs AI | Searching registers manually |
|---|---|---|
| Get an answer | Cited answer in seconds | Read and assemble records yourself |
| Compare markets | Several jurisdictions in one question | Separate national-register searches |
| Check the evidence | Each claim opens its stored source | Collect references as you go |
| Read across languages | Ask and receive answers in yours | Work through each regulator's language |
| Follow the research | Research trail on the answer page | Build your own record of searches |
Official sources for pharma regulatory compliance
Research across FDA, EMA, MHRA, NICE, Swissmedic, PMDA, Health Canada, AIFA, BfArM and other national authorities. The pharma coverage page lists the datasets and jurisdictions. New sources are added weekly.
Every claim links to the stored register entry, list or committee record. A colleague can open the citation and check a date or recommendation. Questions and uploads are never used for training. Data is processed and stored in the EU by default. See security details.
Pricing: start with your first question
Free to try, no credit card. The Free plan includes the full corpus, all jurisdictions and the research trail. Pro costs $100 per user per month, with unlimited questions, deep research and priority speed. Cancel anytime. Enterprise seats, SSO and procurement are available on request.
FAQ
Does it cover reimbursement and HTA?
Yes. Ask about NICE appraisals, AIFA class A listings and prescribing notes, and compare the findings in one cited answer.
How does AI in regulatory affairs pharma research work here?
RegAffairs AI answers from official public records, with source links and a visible research trail. See RegAffairs AI vs ChatGPT.
Ask your first pharma question
Pick a product and ask where it's approved, reimbursed or short. Get a cited answer without a sales call.