Bioequivalence studies for GCC submission [Design Issues]

posted by professionalr – India, 2025-01-31 00:00 (489 d 21:45 ago) – Posting: # 24353
Views: 4,439

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.
—
Thanks,
RP.

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