Large pharmaceutical and biotech companies often generate hundreds of reports each year for regulatory agencies and internal use. These reports, sometimes reaching nearly a hundred pages, contain extensive data from multiple sources, including text and annotations.

One multinational biopharmaceutical company needed to generate hundreds of Chemistry, Manufacturing, and Controls (CMC) dossiers annually as a part of submitting new drugs for FDA approval. Their goal was to cut in half the time needed to generate a CMC, without an increase in staffing.

With BIOVIA Structured Document Authoring, the company streamlined document generation directly from data, eliminating manual data verification. This automation ensures full traceability, builds system trust, and accelerates the review and approval process.

Download the use case to discover how they achieved a 50% reduction in CMC content authoring time.