ROLE AND IMPORTANCE OF DRUG REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY


Sanket B. Gophane, Sachin S. Dighole, Dr. Sunil S. Jaybhaye
Dr. Babasaheb Ambedkar Technological University, Raigad, Lonere, Maharashtra
Abstract
Drug Regulatory Affairs (DRA) plays a central role in guiding pharmaceutical products from early development to successful market entry. It ensures that every medicine made available to patients meets essential standards of safety, efficacy, and quality. Acting as a communication bridge, DRA connects pharmaceutical companies with regulatory bodies at national and global levels. Professionals in this field prepare necessary documentation, coordinate approvals, and help companies follow regulations set by agencies like CDSCO, USFDA, EMA, and WHO. With the growing complexity of drug research and increasing demand for global harmonization, the value of DRA has become even more significant. It supports quality control, ethical conduct of clinical trials, and continuous monitoring of medicines through pharmacovigilance. By ensuring compliance throughout the product’s lifecycle, DRA minimizes risks, prevents harmful outcomes, and protects public health. Ultimately, Regulatory Affairs ensures timely drug approvals and helps deliver safe and reliable medicines to society.
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Journal Name :
EPRA International Journal of Multidisciplinary Research (IJMR)

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Published on : 2025-12-10

Vol : 11
Issue : 12
Month : December
Year : 2025
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