AI in regulatory affairs that cites the official source
Ask a regulatory question and get an answer in seconds, with each claim opening the official source. That is what AI in regulatory affairs should do.
RegAffairs AI is AI for regulatory affairs you can start using yourself today. Free to try.
Try it free · See an example answer. No credit card and no demo call.
The FDA launched Elsa, its staff AI tool, in June 2025. For your team, the useful outcome is an answer you can show QA, legal or an auditor, with the evidence ready to inspect.
Where AI in regulatory affairs saves the most time
Lookups still mean moving between the Orange Book, an EPAR and national registers. A cited answer covers these jobs:
- Status and scope. Is the substance restricted, the product authorised, the classification still harmonised? Ask "Is tirzepatide centrally authorised in the EU?" and get the EPAR facts: Mounjaro, EMEA/H/C/005620, Eli Lilly Nederland B.V., authorised 15 September 2022 (answer).
- Multi-market comparisons. One substance, several jurisdictions, only the differences. The glyphosate ADI across the EU, US EPA, Codex, Japan and Korea comes back in one answer (answer).
- Deadlines and duty holders. Who notifies, by when and under which article, as in REACH Article 33 and SCIP notification (answer).
- Register lookups that used to mean five portals: the Orange Book, EPARs, shortage lists, the C&L inventory, CosIng.
- Change checks after an amendment, an ATP or a court ruling.
AI for regulatory affairs, with the source on the page
Ask in plain language, in any language. A CAS number, a product name, a market or a full sentence is enough. Quick answers take seconds. Deep research mode handles multi-step questions across several markets.
Every claim links to the stored source, down to the paragraph or entry. The research trail is on the answer page, so you can check the market and the date yourself.
| Research check | What RegAffairs AI shows |
|---|---|
| Source | Official registers, regulations and case law |
| Citation | Every claim linked to the stored source, down to the paragraph or entry |
| Cross-jurisdiction research | Several markets answered in one question |
| Research trail | Every search and document shown on the page |
| Getting started | Self-serve, free to try, no demo call |
| Public price | See pricing |
Take "Is TiO2 still harmonised as Carc. 2 under CLP?" The answer cites Delegated Regulation (EU) 2020/217 and the General Court judgment in T-279/20 and T-288/20, paragraphs 105 to 112. It took 6 research steps and 48 seconds. Each citation opens the stored document. More on why that matters: cite the paragraph.
See RegAffairs AI versus in-house AI for the source-backed approach.
AI in regulatory affairs: pharma
Search approvals and EPARs, the FDA Orange Book, shortage registers from FDA, EMA, MHRA and BfArM, GMP inspection outcomes and reimbursement lists. One question covers several markets.
Two answers show the range. Ask for the Orange Book patents and exclusivities for apixaban (Eliquis), plus approved generic ANDAs. You get 30 citations to Orange Book entries (answer). Or ask whether amoxicillin is in shortage in the US, EU, UK and Germany. The example answer compares records from BfArM, EMA, FDA, NHSBSA and others, with report dates next to the findings.
Device teams ask the same way. FDA product code DQY resolves to Catheter, Percutaneous, Class II, 21 CFR 870.1250 (answer). See RegAffairs AI for pharma and pharma regulatory intelligence.
Chemicals, food, cosmetics and pesticides
The same question box covers these too. See the coverage page for current sources.
- Chemicals: "What is the regulatory status of HBCDD in the EU, the US and China?" (answer)
- Food: additives, contaminants, FIC and health claims, like the glyphosate ADI question above.
- Cosmetics: "Which phthalates are restricted in cosmetics, and under which annex entries?" (answer)
- Pesticides: approvals, MRLs and reference values across markets.
Built for regulated teams
Your questions, documents and uploads are never used to train models. Data is processed and stored in the EU by default. Every answer carries its sources and research trail, so a reviewer can retrace it without asking you. Details are on the security page.
AI in regulatory affairs pricing: free to try
The Free plan needs no credit card. It searches the full corpus across all jurisdictions, with cited answers and the research trail. Pro is $100 per user per month: unlimited questions, deep research and priority speed, month to month, cancel anytime. Enterprise is on request, for seats, SSO and procurement. See pricing.
FAQ
How is AI used in regulatory affairs?
For status and scope checks, multi-market comparisons, deadlines and duty holders, and register lookups. RegAffairs AI answers these from official regulatory text, with a citation on every claim.
Can I use ChatGPT for regulatory affairs?
RegAffairs AI gives you source-backed research your reviewer can inspect. It answers from official sources, links every claim to the stored source and shows its research trail.
Does RegAffairs AI work for pharma regulatory affairs?
Yes. Ask about FDA, EMA and national registers, including the Orange Book, EPARs and shortage lists, and get a cited answer across markets.
How much does AI for regulatory affairs cost here?
Free to try, with no credit card. Pro adds unlimited questions and deep research, billed month to month.
Ask your first regulatory question
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