T-License obtained for invitro testing [Regulatives / Guidelines]

posted by drgunasakaran1  – 2013-03-18 11:23 (4847 d 04:07 ago) – Posting: # 10220
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Dear Mr Deepak Sangwan,

❝ but is there any procedure where we can notify the DCGI for conducting BABE study on products procure for in vitro?


Generally, DCGI will not accept the Notification for using the Samples for BA/BE studies for which they actually given Import License for doing In Vitro testing only.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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