REGULATORY AFFAIRS: THE GATEKEEPERS OF PHARMACEUTICAL INNOVATION”: AN OVERVIEW

Vinaya Antony*, Shameema, Ajmala, Fadhiya, Najiya Faizal PT, Junise V, Shafin P

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ABSTRACT

Regulatory affairs (RA) is indeed a critical function within the pharmaceutical industry. It ensures that new
products meet stringent regulatory standards for safety, efficacy, and quality, while also navigating the complex
landscape of regulations to streamline the development and approval process. By acting as a liaison between
project teams and regulatory authorities, RA helps to anticipate and address regulatory requirements, ultimately
facilitating the timely and successful market entry of healthcare products worldwide facilitating industry growth
through the implementation of regulatory affairs. Regulatory affairs specialists play a crucial role in navigating the
complex regulatory landscape, providing essential guidance to pharmaceutical companies, and ensuring
compliance with evolving regulations. Their dedication to upholding the integrity of pharmaceutical products
underscores their commitment to protecting human health and advancing the pharmaceutical industry. Regulatory
affairs (RA) is indispensable for overseeing the lifecycle of healthcare products, providing strategic, tactical, and
operational guidance to ensure regulatory compliance and expedite global product development and distribution.

Keywords: Regulatory affairs, Pharma industry, Regulatory agencies, Regulatory education, RA professionals.