Regulatory answers for pharma teams.

Approvals move through EMA and FDA on different clocks. Shortage lists change weekly. Pharmacovigilance signals accumulate in MAUDE and EudraVigilance. Pricing rules shift market by market. A portfolio means watching dozens of registers at once, in a dozen languages.

RegAffairs AI indexes the primary sources themselves: marketing authorisation databases, clinical trial registries, shortage and recall feeds, GMP inspection outcomes, reimbursement lists. When you ask a question, the answer is assembled from those official records and every claim is pinned to the exact register entry it came from.

Regulatory affairs teams use it for the daily grind: status checks before a submission, multi-market deltas for a label change, shortage exposure across a portfolio, and the paper trail an auditor will ask for. The research trail is on the page, so the answer survives the follow-up question.