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RegisterBioequivalence studies for GCC submission [Design Issues]
Hi friends,
Would it be acceptable to conduct bioequivalence studies for GCC submission at CRO if the facility has already been inspected by the US FDA? We don’t have separate GCC facility approval.
Would it be acceptable to conduct bioequivalence studies for GCC submission at CRO if the facility has already been inspected by the US FDA? We don’t have separate GCC facility approval.
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Thanks,
RP.
Thanks,
RP.
Complete thread:
- Bioequivalence studies for GCC submissionprofessionalr 2025-01-30 23:00 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence studies for GCC submission drgunasakaran1 2025-01-31 03:20
Ing. Helmut Schütz