4 March, 2024

PrimeVigilance’s Strategic Approach to Establishing PMS in Japan for Advanced Therapies

Discover how PrimeVigilance expertly navigated Japan’s regulatory landscape to establish Post-Marketing Surveillance (PMS) for Advanced Therapy Medicinal Products (ATMPs) in record time, overcoming the unique challenges of the cell and gene therapy (CGT) sector.

This case study showcases PrimeVigilance’s agile approach in achieving regulatory compliance and operational readiness for a client with no direct in-country presence, emphasizing tailored pharmacovigilance solutions, strategic partnerships, and deep regulatory insights.

Explore how PrimeVigilance’s skilled Japan team, customized project documents, advanced safety database integration, and collaboration with a local CRO enabled the client to meet Japan’s strict pharmacovigilance requirements. Download the full case study to see how PrimeVigilance empowers clients in the CGT/ATMP sector to achieve compliance and market authorization success in complex regulatory environments.

 

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Efficient PMS Setup for ATMPs in Japan – PrimeVigilance’s Regulatory Expertise for Advanced Therapies

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