21 February, 2023

Expedited Set-Up

Discover how PrimeVigilance expedited Local QPPV set-up across 26 countries, supporting a client’s complex Marketing Authorization Application (MAA) management for biosimilars used in rheumatology indications.

This case study highlights PrimeVigilance’s expertise in navigating diverse regulatory environments, including jurisdictions with limited PV infrastructure and ambiguous legislation, ensuring compliance and timely MAA support.

Learn how PrimeVigilance’s targeted approach—appointing experienced QPPVs, developing detailed regulatory checklists, and providing localized QPPV training—enabled seamless MAA handling and compliance with national pharmacovigilance requirements. Download the full case study to see how PrimeVigilance accelerates MAA processes in multi-region projects, securing operational efficiency and regulatory success for clients in new and complex markets.

 

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Accelerated MAA Support – Expedited QPPV Set-Up Across Diverse Jurisdictions

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