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Case Study on Local QPPV Pharmacovigilance Services

QPPV Deployment Across 11 Countries for PV Compliance 

All Category, Case Studies, Pharmacovigilance /

Customer Requirement A large US-based pharmaceutical company with a broad global footprint, multiple manufacturing sites, and an extensive pharmaceutical portfolio needed reliable local pharmacovigilance (PV) compliance support across 11 international markets covering over 30 marketed products. The brands under its portfolio had significant visibility and consumer demand, making any PV non-compliance a high regulatory and […]

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case study on Resolution of FDA 483 Inspection gaps

Successful Resolution of FDA 483 Inspection Gaps by Expert Pharmacovigilance Support

All Category, Case Studies, Pharmacovigilance, Regulatory /

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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