Sri Ramakrishna Institute of Paramedical Sciences, College of Pharmacy, Sarojini Naidu Rd, Siddhapudur, Coimbatore, Tamil Nadu, 641044
*Corresponding author. E-mail address: sayashree3101@gmail.com (S. Ananthan)
Online Published on 20 January, 2026.
Artificial Intelligence (AI) is transforming pharmaceutical regulatory affairs and Medical Science Liaison (MSL) activities by improving efficiency, accuracy, and decision-making. In regulatory affairs, AI enables automation in dossier preparation, regulatory intelligence, and pharmacovigilance, significantly reducing human error and turnaround times. For MSLs, AI facilitates analysis of large datasets, identification of Key Opinion Leaders (KOLs), and personalized communication with healthcare professionals. Despite these advancements, challenges such as data privacy, algorithmic transparency, and bias in AI algorithms persist. This review synthesizes recent studies and provides insights into the applications, benefits, challenges, and future directions of AI in these critical domains of pharmaceutical operations.
Artificial Intelligence, Regulatory Affairs, Medical Science Liaison, Pharmacovigilance, Regulatory Intelligence, Real-World Evidence, eCTD, Quality by Design (QbD), Machine Learning, Healthcare Data Science
