_____________________________________________________________________________________________________ *Corresponding author: E-mail: Pravin.ullagaddi@gmail.com; Cite as: Ullagaddi, P. 2024. “Leveraging Digital Transformation for Enhanced Risk Mitigation and Compliance in Pharma Manufacturing”. Journal of Advances in Medical and Pharmaceutical Sciences 26 (6):75-86. https://doi.org/10.9734/jamps/2024/v26i6697. Journal of Advances in Medical and Pharmaceutical Sciences Volume 26, Issue 6, Page 75-86, 2024; Article no.JAMPS.118779 ISSN: 2394-1111 Leveraging Digital Transformation for Enhanced Risk Mitigation and Compliance in Pharma Manufacturing P. Ullagaddi a* a Hutton School of Business, University of the Cumberlands, KY, USA. Author’s contribution The sole author designed, analyzed, interpreted and prepared the manuscript. Article Information DOI: https://doi.org/10.9734/jamps/2024/v26i6697 Open Peer Review History: This journal follows the Advanced Open Peer Review policy. Identity of the Reviewers, Editor(s) and additional Reviewers, peer review comments, different versions of the manuscript, comments of the editors, etc are available here: https://www.sdiarticle5.com/review-history/118779 Received: 14/04/2024 Accepted: 19/06/2024 Published: 24/06/2024 ABSTRACT As the pharmaceutical manufacturing industry embraces digital transformation, innovative technologies are being adopted to improve risk management and regulatory compliance. The present study investigates the application of artificial intelligence, machine learning, the Internet of Things, and advanced data analytics in this sector. Integrating these technologies is essential for tackling product quality, patient safety, and operational efficiency challenges. Although the potential benefits are significant, there is a scarcity of comprehensive studies on the implementation and impact of digital technologies, specifically in the context of risk management and regulatory compliance within pharmaceutical manufacturing. The current study aims to address this gap by exploring how digital technologies can be utilized to enable real-time monitoring, predictive maintenance, proactive quality control, and streamlined regulatory compliance processes. Through a systematic literature review and analysis of case studies, best practices, challenges, and strategies for successful digital transformation in the pharmaceutical manufacturing industry are examined. The results emphasize the remarkable potential of digital technologies to enhance risk management, ensure regulatory compliance, and drive operational excellence. The central Review Article