Abstract

A REVIEW ON ROLE OF REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRY

Prof. Pooja Badhe*, Trupti Wagh and Kajal Shirapure

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Abstract

The Regulatory affairs in the pharmaceutical industry play an crucial role as the Pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provides strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The pharmaceutical companies accountable for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies.

Keywords: Regulatory affairs, Pharmaceutical industries, Pharmacy College, Regulatory education.