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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

  1. https://en.m.wikipedia.org/wiki/Regulatory_affairs
  2. .https://www.longdom.org/peer-reviewed-journals/best-review-articles-in-pharmaceutical- regulatory-affairs-19193.html
  3. Dr Sameer ,s.shaikh Rahul p.gaikawad Dr.m.d rageeb md Usman pee vee publication text book of industrial pharmacy 2 pg.no.129,130
  4. http://ijdra.com/index.php/journal/article/view/1/1 badjatya jitendra kumar department of pharmacy,JIT university
  5. Dr. Dinesh P. Kawade Associate Professor Department of Pharmaceutical Chemistry Priyadarshini J. L. College of Pharmacy, Electronic Zone Building, MIDC, Hingna Road, Nagpur- 440016, Maharashtra, India.
  6. https://images.app.goo.gl/iY955pja3oGBELQAA
  7. https://www.ijariit.com Dr. J. Bhavani P.S.V. College of Pharmaceutical Science and Research, Orappam , Tamil Nadu K. Kokila P.S.V. College of Pharmaceutical Science and Research, Orappam, Tamil Nadu M. Agil Kumar P.S.V. College of Pharmaceutical Science and Research, Orappam, Tamil Nadu . International Journal of Advance Research, Ideas and Innovations in Technology.
  8. Helene .I. Dumitriu A regulatory affairs quality manual Text book of good drug regulatory practice pg .no.3
  9. http://creativecommons.org/licenses/by-nc-nd/4.0/ P.Praneeth M.Pharmacy (Pharmaceutical Management and Regulatory Affairs) PG Student, Sri Sivani College Of Pharmacy, Srikakulam, India.
  10. Dougalus.J .Pisano and David .mantus Text book of FDA regulatory affairs A guide for prescription drugs medical devices and biologics second edition August 2003 of no.352
  11. https://images.app.goo.gl/Ko4a5wsuKCUMp6kq6
  12. https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs Elizabeth D .Mayer PhD in alternative careers in science second edition 2006.
  13. https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs I Hagglof ,A Holmgreen in drug Discovery and development second edition 2013.
  14. https://images.app.goo.gl/EED5dVFo6K6br6aR8
  15. Industrial pharmacy   2   unit      3          by   Mr.biswarup        Das,     assistant     professor         of pharmaceutics sips.
  16. https://www.pharmatutor.org/articles/significance-of-pharmaceutical-regulatory-bodies-a-review
  17. https://www.researchgate.net/publication/341985152_A_CONCISE_REVIEW_ON_PHARMACEUTICAL_DRUG_REGULATIONVanampalli Sushma, Swarupa Arvapalli , J.V.C Sharma, B.Kiranmai Joginpally B.R Pharmacy College, Moinabad, Hyderabad. A CONCISE REVIEW ON PHARMACEUTICAL DRUG REGULATION.
  18. https://www.researchgate.net/publication/343684866_AN_OVERVIEW_OF_REGULATORY_AFFAIRS_IN_PHARMACEUTICAL_INDUSTRY
  19. Sumit Kumar*, Rishabh Panwar, Upendra Singh Department of Quality Assurance, D.B.I.P.R, Dehradun, Uttarakhand. International Journal of Research and Development in Pharmacy and Life Sciences.
  20. Mr. Rajesh Dumpala , Mr. Chirag Patil Research Scientist, Dept. F&D-(MS&T) Alembic Research Centre, Vadodara, Gujarat, India. Research Associate, Dept. F&D- (MS&T) Alembic Research Centre, Vadodara, Gujarat, India. International Journal of Universal Pharmacy and Bio Sciences.
  21. http://ijdra.com/index.php/journal/article/view/401 Aishwarya Patil* and Anjali Thakre Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune Maharashtra, India 411018. International Journal of Drug Regulatory Affairs
  22. http://www.ijupbs.com/ Bhushan A. Bhairav* , Megha S. Jadhav , R.B. Saudagar INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO SCIENCES.
  23. https://images.app.goo.gl/L5BF56rocqc5C2Fy7
  24. https://images.app.goo.gl/5xBt8Wpdar51XYVYA T. Anusha, Dr. M.V. Nagabhushanam Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, A.P, India. International journal of Pharmacy and Analytical Research

Photo
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

Photo
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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