Centre for Learning &
Management Development Programms
Management Development Programme on Regulatory Affairs in Pharma and Medical Devices
Pharmaceutical and Medical device companies rely on the regulatory affairs department to ensure their products comply with the industry’s laws, guidelines, and other regulations. The regulatory affairs department of an organization makes sure that the product is developed, manufactured, and regulated at the desired level of quality, safety, and efficacy. They set up strategies and use their scientific and management skills to achieve the goal of quality assurance throughout the lifecycle of a medicinal product. The RA team ensures meeting the standards of filing and submissions and contributing to quality assurance and clinical affairs. Over the years, pharmaceutical and medicinal products’ means of regulatory affairs have rapidly advanced with the transitions in technology and pharmacovigilance. This specialization will give you an overview of Regulatory Affairs in Pharmaceutical and medical devices.