Paper Key : IRJ************673
Author: Onkar Prakash Deshmukh,Abhjit Ramnath Kadam,Priyanka Machhindra Sagar
Date Published: 12 Oct 2023
Abstract
Abstract-Obtaining approval for new products entering the market, ensuring that approval is maintained for as long as the company wants to keep the product for marketing, and providing calculated and operational ways and assistance for working within regulations are all important roles played by regulatory affairs (RA), which also provides ways to speed up the development and delivery of safe and effective healthcare products for everyday people. For graduate students with a scientific background who enjoy working in teams and communicating with others, who can multitask with ease, and who are keen to learn more about the diverse areas of the pharmaceutical industry, regulatory affairs is an appealing career option.Studying the European standards and their requirements for new registration of injectable drugs, studying the practical aspects of various phases of the life cycle of pharmaceutical products, including sterile and non-sterile dosage forms in regulated markets in Europe, studying the product life cycle beginning with product identification through market research and ending with its withdrawal or renewal in the European market, and studying the European standards and their requirements for new registration of injectable drugs are all goals of this review article. The data in this article may contain official information.One of the most important jobs in the pharmaceutical industry is regulatory affairs. The primary focus of regulatory affairs is the lifespan of healthcare products, and it offers tactical, strategic, and operational advice on how to operate within the law to provide safe and efficient healthcare products around the globe. Working in regulatory affairs requires multitasking. People who appreciate working in a team, engaging with others, and learning more about the pharmaceutical industry may consider this position. A career in regulatory affairs is tremendously satisfying. One should be familiar with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) if they intend to work in regulatory affairs.