Pharmaceutical Regulatory affairs and Intellectual Property Rights
Regulatory affairs is a new profession which developed from the governments desire to protect public by controlling the safety and efficacy of products in areas including pharmaceuticals , industrial pharmacy, veterinary medicines, medical devices. Regulatory Affairs is involved in the development of new medicines from early stage, by incorporating regulatory principles, by preparing and submitting the relevant regulatory documents to health authorities. Regulatory Affairs is actively involved in every step of development of a new medicine and in the post-marketing activities with authorized medicines. The Regulatory Affairs department is an essential part of the organizational structure of pharmaceutical industry. Internally it assist at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.