Dossier preparation cycle down 40%, every document inconsistency caught before submission

A single drug registration submission runs to thousands of pages across clinical, CMC and nonclinical teams. Inconsistent data definitions, versions and terminology between documents were the main cause of deficiency letters from reviewers, and the regulatory team spent much of its time on manual cross-checks.

With several pipeline programs moving in parallel, the company needed a shorter submission preparation cycle and a lower risk of deficiency letters.

We launched a document Agent built around the regulatory team's cross-checking work, from writing support through pre-submission checks.

• Writing support: first drafts of summary modules generated from clinical study reports and data tables, with a source citation for every paragraph
• Consistency check: figures, terminology and versions compared across modules, producing a list of discrepancies
• Regulatory requirement mapping: dossier completeness checked item by item against submission guidance
• Deficiency history library: past reviewer questions are stored, and high-frequency issues are pre-screened automatically before submission

Documents are processed in a controlled environment integrated with the electronic document management system, with versions and approval status kept in sync. Every model output carries source citations and enters the formal document only after a regulatory specialist confirms it.