review on vital role of regulatory affairs in pharmaceutical industry

Abstract

The burgeoning field of Regulatory Affairs (RA) serves as the foundation for ensuring public health in today's globalized marketplace. In the pharmaceutical industry, regulatory affairs play a crucial role in assuring the safety, efficacy, and quality of drug products, which are essential for the approval of new products entering the market. Emerging from a collective international desire to protect individuals from potentially harmful medications, this profession bridges the gap between pharmaceutical companies and regulatory agencies, ensuring that products meet all necessary legal and scientific standards.Regulatory affairs professionals act as guardians, meticulously ensuring the accuracy and completeness of product information. They navigate the complex labyrinth of regulations, translating them into practical plans for companies to follow. Their expertise encompasses the entire life cycle of a drug, from initial application submission and oversight of clinical trials to ongoing adherence to evolving regulatory requirements. This comprehensive approach guarantees the development, manufacturing, and distribution of safe and effective medications across various fields, including traditional pharmaceuticals, veterinary medicine, medical devices, and complementary therapies.As the pharmaceutical landscape continues to evolve, the demand for highly skilled regulatory affairs professionals remains strong. In India, the Central Drug Standard Control Organization (CDSCO) regulates drug legislation, facilitating drug development from initial research to market approval and post-marketing surveillance.