Understands and interprets complex global guidelines from bodies like the FDA and EMA to ensure submission compliance.

Intelligently extracts and structures key data from dense scientific documents like clinical study reports and trial protocols.

Scrutinizes submission dossiers and promotional materials against regulatory standards to identify gaps and inconsistencies before submission.

Drafts accurate, data-backed responses to complex questions from health authorities by synthesizing information from the entire dossier.

Accelerates the creation of regulatory documents, summaries, and product labels using approved templates and scientific data.

Continuously monitors for changes in global regulations and assesses their impact on existing products and internal procedures.