Bioequivalence and Bioavailability Forum

❝ 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.

If the CRO has been approved in the last two years by two of the following drug regulatory agencies such as US FDA, Health Canada, TGA - Australia, UK MHRA, EMA, or WHO, along with one additional authority from the list, then you can include CRO name in the list of bioequivalence centers approved by GCC and you can conduct studies for GCC submission.