Pharma and medtech regulation is dense, multilingual, and unforgiving. RegAI ingests FDA, EMA, MDR, GVP, and ICH text natively in 20+ languages, extracts requirements with traceback to the original-language paragraph, and produces audit-ready evidence packs.
Multilingual ingestion (24 EU official languages plus Asian/Middle East). Every output linked to a specific paragraph in the source — including in the source language.
EMA texts in French, German, Italian; PMDA in Japanese; NMPA in Chinese. RegAI parses each natively and stores the original paragraph alongside the working-language translation. Legal review verifies intent against the source, not a black-box translation.
Pharma audits don't end. Every requirement, gap score, and draft control is linked back to its source paragraph; every AI suggestion → human accept / edit / reject is timestamped. Internal QA, FDA, and EMA all see the same evidence trail.
A 45-minute walkthrough on a slice of FDA / EMA / MDR text and a sample SOP. We bring the platform.
