Artificial Intelligence in Regulatory Submissions and Compliance Management in the Pharmaceutical Industry

Artificial Intelligence (AI) is transforming regulation submission and compliance management by bringing innovative solutions to the pharmaceutical sector. The processes of Investigational New Drug (IND), New Drug Application (NDA), Biologics License Application (BLA), and Abbreviated New Drug Application (ANDA) have become complicated in recent years, requiring a substantial amount of information, extensive data evaluation, and close conformity to regulatory requirements. The application of artificial intelligence in regulatory science has proven effective in automating dossier preparation, enhancing regulatory intelligence, improving regulatory document analysis, facilitating rapid literature searches, and shortening submission times. Moreover, AI is applied in compliance management to achieve continuous control of processes, risk management, audit readiness, pharmacovigilance, and real-time regulatory intelligence while ensuring safe drug production. However, there are several challenges facing the use of AI in regulation submission and compliance management, including data privacy, regulatory constraints, implementation costs, and model transparency. These challenges could be addressed through improved validation methods and a solid understanding of the data’s credibility for building appropriate AI models. Artificial intelligence has vast potential in revolutionizing the pharmaceutical sector and achieving patient-centric drug development while ensuring safe, efficient, and high-quality pharmaceutical products.