ANVISA and Malaysian authorities invitation to audit CRO [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2016-11-02 16:13 (3022 d 06:46 ago) – Posting: # 16765
Views: 3,500

Dear Rasha_J
Bioequivalence studies which should support submissions for generic drugs in Brazil are only accepted by ANVISA if the CRO (clinics and bioanalytical lab) is authorized, i.e. you need to invite ANVISA first before initiating a study for the Brazilian market.
Unfortunately I have no experience with Malaysian authorities. I only know that studies with the European RLD needed to be repeated and the Malaysian authorities can be quite complicated...

Kind regards and have a nice day
Dr_Dan

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