AI in Regulatory Submissions Explained: Complete Guide to Automation, Compliance, and 2025 Best Practices Harnessing AI in Regulatory Submissions: Strategies for Compliance and Efficiency Introduction to AI in Regulatory Submissions Artificial Intelligence (AI) is transforming the pharmaceutical regulatory landscape. From dossier compilation to lifecycle management, AI-driven tools are enabling companies to streamline submissions, improve accuracy, and reduce timelines. Agencies such as the FDA, EMA, and CDSCO are exploring ways to integrate AI within regulatory submissions, particularly in areas like electronic Common Technical Document (eCTD) preparation, regulatory intelligence, and dossier validation. By 2025, AI adoption in regulatory affairs is moving from…