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44. 44 API/Regulatory Filings/Slideshow/Version-00 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 This presentation is the part of knowledge sharing management and not for implementation.

45. 45 API/Regulatory Filings/Slideshow/Version-00 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: ssaravanaraja@enalteclabs.co.in ssaravanaraja@enalteclabs.co.in