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Abstract

Regulatory affairs in the pharmaceutical industry play an important role as the pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a profession which acts as the interface between pharmaceutical industries and government authorities across the world. The goal of the regulatory affairs professional is the protection of human health, ensuring safety, efficacy, and quality of drugs, ensuring appropriateness and accuracy of product information. This present article discusses the evolution of Regulatory Affairs, its role in the pharmaceutical industry and its involvement for the implementation of regulatory guidelines which improve the growth of the industry.

Keywords

Regulatory Affairs, Pharmaceutical industries , world regulatory bodies CDSCO,FDA EMA TGA USFDA

Reference

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Vaibhav Bhausaheb mote
Corresponding author

Nandkumar Shinde College Of Pharmacy , Aghur, Vaijapur 423701 Dist- Aurangabad, Maharastra

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S.S.Devkar
Co-author

Nandkumar Shinde College Of Pharmacy , Aghur, Vaijapur 423701 Dist- Aurangabad, Maharastra

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R.M.Kawade
Co-author

Nandkumar Shinde College Of Pharmacy , Aghur, Vaijapur 423701 Dist- Aurangabad, Maharastra

Vaibhav B. Mote *, Shivprasad S. Deokar, Rajendra M. Kawade, An Overview Of Regulatory Affairs In Pharmaceutical Science, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 567-579. https://doi.org/10.5281/zenodo.10408767

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