OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION
Journal Title: International Journal of Drug Regulatory Affairs - Year 2013, Vol 1, Issue 1
Abstract
Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrum covering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulated industries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceutical industries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized various industries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a very specific meaning within the pharmaceutical industries. DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionals are dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples. RA as profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labeling or in advertising.
Authors and Affiliations
Jitendra Kumar Badjatya
Keywords
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