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IEC approval window period [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2013-09-06 10:22 (4673 d 22:37 ago) – Posting: # 11446
Views: 3,668

Hello to All of you,

We want to conduct bioequivalence study on a IEC approved protocol (in 2011) and DCGI approved protocol (in 2011) now.

So is there any criteria of IEC approval and DCGI approval window period

Is it necessary to send protocol for reapproval

Regards,
Suchit Bhavsar

Complete thread:

IEC approval window periodsuchit_bhavsar 2013-09-06 08:22
- IEC approval expiry date Dr_Dan 2013-09-06 10:53
- changed requirements Helmut 2013-09-06 13:43
- IEC approval window period raghu 2013-09-06 13:53

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