• Soham S. Shegokar
• Dr. Shivshankar D. Mhaske
• Dr. Harshal Anwane
• Prajwal B. Surwade

Regulatory affairs in the pharmaceutical sector encompass the management of various registration parameters for pharmaceutical products. This profession emerged globally to safeguard public health by ensuring that drugs meet high standards of safety, efficacy, and quality, not only in pharmacy but also in veterinary medicine, medical devices, agrochemicals, cosmetics, and other related fields. Regulatory affairs professionals serve as a vital link between pharmaceutical companies and regulatory bodies. They are responsible for ensuring the accuracy and appropriateness of product information, while also advising companies on regulatory requirements and translating these into actionable plans. In the rapidly growing pharmaceutical industry, regulatory affairs specialists play a crucial role in helping companies meet global competition by ensuring compliance with evolving industry standards. Their primary goal is to protect human health by ensuring that medicines are safe, effective, and of high quality, while also maintaining the accuracy of product details. This article explores the evolution of regulatory affairs, its significance in the pharmaceutical industry, and its role in implementing regulatory guidelines that foster industry growth.

Regulatory Affairs, Pharmaceutical industries, regulatory bodies.

"REVIEW ON PHARMA INDUSTRY REGULATIONS AND REGULATORY AFFAIRS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 12, page no.h179-h197, December-2024, Available :http://www.jetir.org/papers/JETIR2412723.pdf

"REVIEW ON PHARMA INDUSTRY REGULATIONS AND REGULATORY AFFAIRS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 12, page no. pph179-h197, December-2024, Available at : http://www.jetir.org/papers/JETIR2412723.pdf