ROLE OF REGULATORY AFFAIRS IN THE PRODUCTION OF PHARMACEUTICAL PRODUCTS IN ALL OVER THE WORLD

Vidhya Jakky* and Harika Chollangi

ABSTRACT

The production of pharmaceutical products is a complex and tightly regulated process that requires adherence to stringent standards to ensure safety, efficacy, and quality. Regulatory affairs professionals play a pivotal role in navigating the intricate landscape of global regulations and guidelines governing the development, manufacturing, and distribution of pharmaceuticals. This paper examines the indispensable role of regulatory affairs in the production of pharmaceutical products across the world. It explores how regulatory professionals collaborate with various stakeholders, including government agencies, pharmaceutical companies, and healthcare providers, to ensure compliance with evolving regulatory requirements. The paper delves into the key responsibilities of regulatory affairs professionals, such as compiling regulatory submissions, managing product approvals, and ensuring post-market compliance. It also highlights the challenges posed by varying regulatory frameworks in different regions and the efforts towards international harmonisation. By fostering a comprehensive understanding of the role of regulatory affairs, this paper underscores the vital contribution of regulatory professionals in safeguarding public health and maintaining the integrity of the pharmaceutical industry.

Keywords: Regulatory affairs, Pharmaceutical products, Global regulations, Compliance, Product approvals, regulatory submissions, Healthcare, International harmonisation.