Offline Course

The Master of Pharmacy (M.Pharm.) in Regulatory Affairs is a specialized postgraduate program designed to provide students with comprehensive knowledge of pharmaceutical regulations, drug approval processes, and global regulatory frameworks. The program prepares students to navigate the complex regulatory landscape governing the development, manufacturing, and commercialization of pharmaceutical products.

This course covers key areas such as drug regulatory affairs, intellectual property rights, documentation practices, regulatory writing, and international regulations including those from USFDA, EMA, CDSCO, MHRA, and WHO. Students gain hands-on experience with dossier preparation, regulatory submissions, and quality documentation, enabling them to ensure compliance in global markets. The program plays a crucial role in preparing professionals to bridge the gap between scientific development and legal/regulatory requirements in the pharmaceutical industry.