Regulatory Filings of Active Pharmaceutical Ingredients

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Transcript Regulatory Filings of Active Pharmaceutical Ingredients

Regulatory Filings of
Active Pharmaceutical
Ingredients - An Eagle’s Eye view
[US and Europe]
Saravanaraja Subramanian
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http://www.emea.europa.eu/index/authorisation.htm
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http://www.emea.europa.eu/htms/human/raguidelines/pre.htm
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http://www.emea.europa.eu/htms/human/raguidelines/post.htm
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Disclaimer: The whole power point presentation is intended to give a basic idea of regulatory filings of API in US and
EU region to all readers. This does not confer any rights or privileges by any body to propose or decide the filing
category of changes to approved marketing authorization. This presentation is the part of knowledge sharing
management and not for implementation.
About the Author
Mr.Saravanaraja Subramanian is employed with Enaltec Laboratories Limited,
India, as Dy.General Manager – Quality Assurance and Regulatory Affairs. He
is having good amount of experience and vast knowledge in the areas of Quality
Assurance, Quality control, Validation and Regulatory Affairs. He is specializes
in Pharmaceutical Microbiology. He can be reached by on his mobile phone at
0091-9699995911, and via at e-mail at: [email protected]