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Rasha_J ☆ Jordan, 2016-11-01 10:07 (2724 d 20:58 ago) Posting: # 16763 Views: 3,806 |
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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  |
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Dr_Dan ★★ Germany, 2016-11-02 16:13 (2723 d 14:51 ago) @ Rasha_J Posting: # 16765 Views: 3,137 |
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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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Rasha_J ☆ Jordan, 2017-05-11 08:58 (2533 d 23:06 ago) @ Dr_Dan Posting: # 17349 Views: 2,048 |
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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 |
Ing. Helmut Schütz