Abstract

A REVIEW ON REGULATORY AFFAIRS AS INTEGRAL PART OF PHARMACEUTICAL INDUSTRY

Saddam Husain*, Akanksha Sharma and Sanjiv Duggal

ABSTRACT

Since the pharmaceutical industry is expanding quickly and there is a shortage of regulatory affairs specialists to meet the sectors' present demands in light of global competitiveness, regulatory affairs play a significant role in the pharmaceutical sector. A regulatory affairs professional serves as a liaison between the pharmaceutical industry and international government agencies. The preservation of human health, the safety, effectiveness, and quality of medications, as well as the appropriateness and accuracy of product information, are the objectives of regulatory affairs professionals. The evolution of regulatory affairs, its function in the pharmaceutical sector, and its involvement in putting regulatory standards into effect that enhance industry growth are all covered in this article.

Keywords: Regulatory affairs, History, Role and Resposibilties, new amendments.