Exploring the advancements and challenges of digitalizing eCTD using AI software tools

The traditional workflows are challenged by complex lifecycle management and increasing data volumes, despite the fact that the electronic Common Technical Document (eCTD) is the global standard for regulatory submissions. Common Technical Document (CTD) is a standardized document which is developed by the International Council for Harmonisation (ICH) for providing information required in regulatory submissions for pharmaceutical registration. electronic Common Technical Document (eCTD) is electronic format of CTD utilised for providing information for regulatory authorities using ai software tools.  Automation, standardization, and analytics are changing the way that submissions are prepared thanks to regulatory systems powered by artificial intelligence (AI). This evaluation examines the ways in which AI-powered solutions update eCTD procedures, concentrating on LORENZ docuBridge, Veeva Vault RIM, and EXTEDO. Structured content management, automated publishing, metadata-based dossier building, validation checks, and regulatory tracking are among the key capabilities that were examined. The contribution of AI techniques is examined in terms of quality, speed, and risk reduction. These techniques include intelligent document classification, content reuse, rule-based compliance verification, and predictive regulatory insights. In comparision with CTD shows that these platforms facilitate effective lifecycle management, boost cross-functional cooperation, and improve data integrity. This review describes AI-enabled regulatory software creates a more intelligent regulatory process that speeds up and simplifies compliant submissions, thereby helping patients.