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The following message was posted to: PharmPK
My Question is
01. How do we go for ANVISA accreditation for the clinical unit doing
BA /
BE studies ?
Regards
SUDHEENDRA K
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The following message was posted to: PharmPK
Dear Mr. Sudheendra,
To conduct BA/BE studies for the products to be marketed in Brazil,
ANVISA
has made it mandatory that the site be audited and certified by them.
You will have to fill an application form available at
http://www.anvisa.gov.br/eng/bio/index.htm
There is a checklist posted in the ANVISA website, which will help you
in
planning for the audit.
http://www.anvisa.gov.br/eng/legis/resol/103_03rdc_e.htm
Fulfilling the checklist will help you in gaining accreditation.
Regards
Ganesh
M.M. Ganesh
Clinical Pharmacology Unit
Majeedia
Tel: 011-29959588
My Web Page: www.geocities.com/ganaish/gans
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