OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

  • Jitendra Kumar Badjatya Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India

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.

Keywords: Keywords: Regulatory Affairs professionals, Regulatory agencies, CDER, MHRA, MOH

Downloads

Download data is not yet available.

Author Biography

Jitendra Kumar Badjatya, Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India

Research Scholar, Department of Pharmacy, JJT University, Chudela, Jhunjhunu, Rajasthan. India

References

1. Regulatory Affairs from Wikipedia, the free
encyclopedia modified on 7th April available at
http://en.wikipedia.org/wiki/ Regulatory_ Affairs.
2. International regulatory affair updates 2005 available
at http://www.iraup.com /about.php
3. “Douglas J Pisano and David S. Mantus” ‘Text book
of FDA Regulatory Affairs A Guide for Prescription
Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc.
available at http://www.cgmp .com/ra.htm.
5. Science career brought by American association 2011
available at http:/ /sciencecareers.sciencemag.org
/career_magazine/previous_issues/articles/
1999_12_24/no DOI.1 20792759800514086 99.
6. Topra brought by dimension associates available at
http://www.topra.org /care ers/whatregulatory-affairs.
7. Training Needs in Regulatory Science for the
Biopharmaceutical Industry,” Naturejobs Biotechnology,
2001, 19 (12) 1187-1188.
8. “Careers in Regulatory Affairs from Practitioner to
professional,” Naturejobs Biotechnology, 2002, 20(4),
409-410.
Statistics
412 Views | 1895 Downloads
How to Cite
Badjatya, J. K. “OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 1, Feb. 2013, pp. 1-4, doi:10.22270/ijdra.v1i1.1.