The Duties of Drug Regulatory Affairs in the Pharmaceutical Sector

Main Article Content

Mayur Dandekar

Abstract

A product’s long-term performance in the healthcare system is a priority for the regulatory affair (RA) team
of the pharmaceutical sector. To meet regulatory requirements while accelerating the development and
distribution of safe and efficient medical products to people throughout the world, they provide strategic,
tactical, and operational guidance and assistance. Creating and implementing a regulatory plan that ensures
the drug research group’s combined efforts result in a product that not only satisfies international regulators
but also sets itself apart from the competition is the responsibility of RA. The goal of using Common Technical
Documents is to significantly reduce the amount of time and money that business must spend assembling
applications for worldwide registration. A controlling specialized is a person who attends as a liaison amid
foreign government bodies and medicinal businesses. RA professionals ensure that pharmaceuticals are
benign, effective, and of high quality. They also ensure that product information is accurate and appropriate.
All of these efforts contribute to the protection of public health. This section covers the evolution of RA, their
function in the pharmaceutical business, and their involvement in enforcing laws that support the sector’s
expansion.

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How to Cite
Dandekar, M. (2024). The Duties of Drug Regulatory Affairs in the Pharmaceutical Sector. Asian Journal of Pharmaceutics (AJP), 18(04). https://doi.org/10.22377/ajp.v18i04.5845
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