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Pharmaco Vigilance

We cover a wide range of areas regarding safety and pharmacovigilance in Japan:

Strategic Advice and Operational Support on any aspect related to safety and pharmacovigilance in Japan
Assessment and Review of safety documents (Module 1, Module 2, RMP, etc.) for submissions to PMDA
Gap Analysis of global documents to meet Japan-specific requirements
Preparation and Review of SOPs for GVP (Good Vigilance Practice) and GPSP (Good Post-marketing Study Practice)
Consultation and Interactions with PMDA regarding safety matters
Strategy and Management of PMS, EPPV, Periodic Safety Reports

We are your gateway for success in Japan

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We epitomize the perfect combination of a robust strategy with active communication and effective execution. We are honoured to be a dedicated partner for your success in Japan!  

4.9 out of 5 stars from 47 reviews
★★★★★ 4.7/5

We provide flexible, reliable and client-focused services to meet your needs in Japan. 

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