07-09-2022

Regulatory Affair's

 An specialized Profession within Pharmaceutical/ Biotechnology/Nutraceutical

Sector.
 It’s a important part of any pharmaceutical companies which
Internally - liaises at the interphase of development, manufacturing and marketing,
Externally – key interphase at company and regulatory bodies
 Oversees companies compliance with regulations and law pertaining to
manufacturing, Marketing, and development of regulated products.
 Act as a point of contact between the company, Its products and regulatory
authorities.
 Regulatory affairs interact with various regulatory authorities world wide and local
agencies for licensing, registration, manufacturing, marketing and labelling

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History

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References:

• https://www.pharmaguideline.com/2012/12/regulatory-affairs.html
• https://www.jetir.org/papers/JETIR1908771.pdf
• https://www.hilarispublisher.com/open-access/historical-overview-of-pharmaceutical-
industry-and-drug-regulatory-affairs-2167-7689.S11-002.pdf
• https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs
• https://www.internationaljournalssrg.org/IJPBE/2016/Volume3-Issue1/IJPBE-
V3I1P101.pdf
• https://www.pharmatutor.org/articles/an-overview-of-regulatory-affairs-and-its-
importance-in-pharmaceuticals-other-industries
• https://www.cliniindia.com/regulatory-affairs/
• https://www.internationaljournalssrg.org/IJPBE/2016/Volume3-Issue1/IJPBE-
V3I1P101.pdf