Regulatory Affair: Link between company and Government Authority

  • Posted on: 1 June 2014
  • By: admin

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PharmaTutor (June- 2014)
ISSN: 2347 - 7881


Received On: 02/04/2014; Accepted On: 06/04/2014; Published On: 01/06/2014


AUTHORS: Yogeshkumar B. Viradiya
Department of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),
Nagpur, Maharashtra.


Regulatory affair is the very important department in Pharmaceutical Company. For the protection of public health, government of various countries have developed the regulation for pharmaceutical, cosmetic product, pesticides, veterinary medicines, medical device, agrochemical and complementary medicines by controlling the safety and efficacy of product. Regulatory affair department prepare the registration document which submits to the regulatory agency of various countries for approval of new drug which contain the all important information about new drug. It is called the drug master file of Common technical document (CTD). Regulatory affair is the link between company and government authority. Regulatory affair is important for Product management, Clinical trial, Research & Development. Regulatory personnel have to maintain contact with other specialist like chemist, doctors, veterinarians, engineers, pharmacologist, toxicologist, pharmacists, and accountant. Regulatory authorities of different countries prepare their separate rules and regulation. Main aim of regulatory affair department is to provide safe and effective medicine to people of different companies. Separate rules and regulation in different countries which must be followed by all pharmaceutical company in all over the world.

How to cite this article: Y Viradiya; Regulatory Affair: Link between company and Government Authority; PharmaTutor; 2014; 2(6); 9-20