29 Apr Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)
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The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies.
It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt. Ltd. The document provides HCRs with instructions on how to proceed with applications containing BE studies from Synapse Labs Pvt. Ltd.
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Document Number:
PEM01-2025 | CEM01-2025
Version:
1
Date Updated:
29/04/2025
File Type:
pdf
Category:
Communication to industry