Anonymized · Pharma R&D
Regulatory document AI for a pharma R&D unit
Problem
Regulatory dossiers were assembled manually from hundreds of source documents — PDFs of varying vintages, spreadsheets, scanned forms — with the same data re-entered three or four times before submission. Reviewers spent more time chasing inconsistencies than evaluating the science.
Approach
We built a multimodal document pipeline that classified and parsed source artifacts, then surfaced extracted fields in the customer's existing review tool. Each extraction carried a confidence score, a link back to the source pixel region, and a human-in-the-loop checkpoint. The eval harness ran on every model update before promotion.
Outcome
Submission preparation time reduced materially; reviewer time shifted from data entry to scientific judgment. The pipeline runs on the customer's Korean cloud infrastructure with full lineage from source PDF to submitted artifact, satisfying the FDA-EMA guidance principles for AI in regulatory decision-making.