The Transformative Drug Impact of AI in Pharmaceutical Drug Product Development

Artificial Intelligence (AI) is transforming the pharmaceutical industry by streamlining drug discovery, optimizing clinical trial processes, and advancing personalized medicine. In addition to these innovations, AI is increasingly being applied in pharmaceutical regulatory affairs to automate regulatory submissions and manage documentation more efficiently. This review provides an overview of how AI is currently being utilized in drug development and regulatory processes. It examines significant case studies and recent technological advancements, while also addressing the challenges and regulatory implications of integrating AI in these domains. With the AI-driven drug discovery market experiencing rapid growth [1], it is essential for both industry professionals and academic researchers to understand how AI is being incorporated into pharmaceutical workflows.