Diploma in Regulatory Affairs

Diploma in Regulatory Affairs

1 year

One Year Diploma Program in Regulatory Affairs is designed to equip professionals and students with a comprehensive understanding of regulatory frameworks governing pharmaceuticals, biotechnology, medical devices, and healthcare products. With the increasing globalization in healthcare sector, regulatory compliance has become a critical aspect of product development, approval, and commercialization. This program provides an in-depth exploration of international regulatory guidelines, including those set by USFDA, EMA, CDSCO, ICH, WHO, and other global regulatory bodies. It covers key aspects such as drug development, clinical trial regulations, dossier preparation, quality assurance, and post-market surveillance. The curriculum integrates theoretical knowledge with practical case studies to enhance analytical and decision-making skills in regulatory affairs. The program offers flexibility for working professionals, academicians, and fresh graduates aspiring to build a career in regulatory compliance with a multidisciplinary approach, fostering expertise in both scientific and legal aspects of regulatory affairs. Upon successful completion, graduates will be well- prepared for careers in pharmaceutical industries, healthcare organizations, regulatory agencies, and consultancy firms, contributing to the seamless regulatory approval and market access of healthcare products worldwide.