This study aimed to address the challenges with the current landscape for managing generic product registration globally. Highly complex regulatory environment, varied approval timelines, specific data requirement including costly and time taking Chemistry, Manufacturing, Control data and Bioequivalence studies data, between countries have been an issue for industry to ensure uninterrupted supply of high quality, safe and effective medicines around of the world. The approval globally. The author expects that this will bring consistency to managing generic product registrations globally, contribute in global convergence and enhance global public health by ensuring timely access to quality medicines for patients. study aimed to understand the opportunities using Regulatory Intelligence and recommendations to build a global dossier in line with Health authorities’ expectations, as it could save significant cost and time, and ensure swift and timely

Regulatory Intelligence, Regulatory Affairs, Generic Pharmaceutical Products, Product Development, Global Dossier.