professionalr ☆ India, 2025-01-31 00:00 (13 d 10:03 ago) Posting: # 24353 Views: 296 |
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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. |
drgunasakaran1 ★★ ![]() 2025-01-31 04:20 (13 d 05:42 ago) @ professionalr Posting: # 24354 Views: 255 |
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❝ 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. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |