Abstract

REGULATORY AFFAIRS ROLE IN PHARMACEUTICAL PRODUCT MANUFACTURING

Pemmaraju Sowjanya*, Golipally Deekshitha, Kanaje Divya, Kummari Surendra and T. Rama Rao

ABSTRACT

Regulatory Affairs (RA) plays a pivotal role in the pharmaceutical industry, ensuring that all products meet rigorous safety, efficacy, and quality standards throughout their lifecycle. This review provides a comprehensive overview of the function and significance of RA in pharmaceutical product development, from early drug discovery to post-marketing surveillance. It highlights the responsibilities of RA professionals in navigating the complex legal and regulatory landscapes across global markets, facilitating communication with agencies, and maintaining compliance with evolving guidelines. The article discusses key regulatory bodies worldwide, outlines the drug development process, and emphasizes the importance of Good Manufacturing Practices (GMP) and International Council for Harmonisation (ICH) guidelines. Additionally, a review of relevant literature demonstrates the expanding role of RA in strategic planning and compliance, reinforcing its integral position in bringing safe and effective pharmaceutical products to market. This review underscores RA’s contribution to public health and its growing impact amidst advancing technologies and global regulatory harmonization.

Keywords: Regulatory affairs, Post marketing surveillance, Good Manufacturing Practices.