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Back to the forum  Query: 2017-11-20 08:48 CET (UTC+1h)
 
Quality-RJ
Junior

Jordan,
2016-11-01 09:07

Posting: # 16763
Views: 2,077
 

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

Hello to all...

Can any one advise if we can invite ANVISA and Malaysian authorities to inspect CRO in Jordan or it has to be upon study submission

Thanks in advance for your help :-)
Dr_Dan
Senior

2016-11-02 15:13

@ Quality-RJ
Posting: # 16765
Views: 1,662
 

 ANVISA and Malaysian authorities invitation to audit CRO

Dear Quality-RJ
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
Quality-RJ
Junior

Jordan,
2017-05-11 06:58

@ Dr_Dan
Posting: # 17349
Views: 623
 

 ANVISA and Malaysian authorities invitation to audit CRO

Dear Dr_Dan

Thank you a lot for kind feedback. To submit to Malaysian authorities, seems that it should be through a local company registered there (somehow like Turkish authorities).


thanks again
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