case study on Resolution of FDA 483 Inspection gaps

Successful Resolution of FDA 483 Inspection Gaps by Expert Pharmacovigilance Support

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Customer Requirement An India-based pharmaceutical company engaged in research and development (R&D) and manufacturing, faced critical challenges after an US FDA inspection revealed significant gaps in its pharmacovigilance (PV) compliance. The company required comprehensive support to address issues related to Individual Case Safety Reports (ICSRs) and Periodic Adverse Drug Experience Reports (PADERs) to comply fully […]

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