PharmD Info

A forum for Indian Pharmacy Professionals

Drug Regulatory Affairs - CMC Regulatory, Global regulatory, Medical Devices, Pharmaceutical Regulatory Details PPT and Guidelines and etc.
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A drug regulatory affair 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.

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.
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