PHARMA INITIATIVE SUPPORT

Pharma Initiatives Supports helps innovative product development through providing clinical development expertise and regulatory expertise in Japan toward successful commercialization in Japan. In detail, Pharma Initiative Support reviews all relevant data including non-clinical data and provides clinical development strategies and plan after gap analyses. Pharma Initiative Support also supports negotiations with regulatory authorities including PMDA, for instance PMDA consultations, Orphan Drug Designation(ODD), Sakigake Designations. We support an execution of Global clinical studies. We also support Japan-NDA and successful regulatory approvals... Overview of Services Regulatory Authorities have been a... Yoshi Shinoki, Representative Director, founded Pharma Initiative Support (PIS) in 2019. PIS delivers value added and innovative solution to develop product development strategy and Implementation plan based on well trained experiences of clinical development, Project Management..