ABSTRACT:
Regulatory Affairs is a critical function in industries such as pharmaceuticals, biotechnology, medical devices, food and beverages, and cosmetics, focusing on ensuring that products comply with the relevant regulations and standards imposed by government bodies. The primary goal of Regulatory Affairs professionals is to facilitate the approval and market access of products while ensuring compliance with local and international laws, safety standards, and ethical practices. The RA process involves navigating complex regulatory frameworks, preparing submissions for product approval, interacting with regulatory agencies, conducting clinical trials, and ensuring post-market surveillance. Effective Regulatory Affairs practices can reduce the time-to-market for new products and mitigate potential legal and compliance risks for companies. Additionally, RA professionals are responsible for managing and updating product labels, ensuring proper advertising and marketing practices, and addressing regulatory changes that may affect product development and distribution.
Cite this article:
Raj Ganesh Mahajan, Devesh Pravinkumar Bhavsar. Review on Regulatory Affairs in Pharmaceutical Industry. IJRPAS, December 2025; 4(12): 105-110.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.41210
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