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UNVEILING THE POWERHOUSE: A REVIEW OF A VITAL ROLES OF DRUG REGULATORY AFFAIRS


Ms.Swapnali Sanap, Mr. Akash Shelke, Ms.Pradnya Walave, Ms.Payal Sakat
Shri Swami Samarth Institute of Pharmacy, Malwadi (Bota), 422602, (MH), India.
Abstract
The role of regulatory affairs in the pharmaceutical industry is crucial because the sector is expanding quickly and requires specialists in this field to meet the demands of modern industries competing on a global scale. A regulatory affairs professional serves as a liaison between the pharmaceutical industry and international government authorities. The regulatory affairs specialist works to protect human health by guaranteeing the effectiveness, safety, and appropriateness of pharmaceuticals, as well as the correctness and appropriateness of product information.Professionals in regulatory affairs (RA) are essential to the pharmaceutical industry because they care about the healthcare product lifecycle, offer operational, tactical, and strategic guidance, and support in adhering to regulations to hasten the development and distribution of safe and effective healthcare products to people all over the world. Regulatory affairs is responsible for creating and carrying out a regulatory strategy to guarantee that the combined efforts of the drug development team produce a product that is approved by international regulators while also setting the company apart from its competitors in some way.
Keywords: Regulatory, Registration, Hormonization, Purity,Safety.
Journal Name :
EPRA International Journal of Multidisciplinary Research (IJMR)

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Published on : 2023-12-04

Vol : 9
Issue : 12
Month : December
Year : 2023
Copyright © 2024 EPRA JOURNALS. All rights reserved
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