APPLICATION OF ARTIFICIAL INTELLIGENCE FOR AUTOMATION OF REGULATORY DOSSIER PREPARATION (CTD/eCTD)

The pharmaceutical industry operates under stringent regulations, requiring companies to submit comprehensive documentation for drug approval, marketing authorization, and post-marketing surveillance. The Common Technical Document (CTD) and its electronic version, eCTD, are standardized formats used globally to facilitate regulatory submissions across multiple regions. These dossiers contain vast volumes of information, including quality, safety, efficacy data, clinical trial results, and manufacturing details.