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Japanese Regulatory Strategy & PMDA consultation

Regulatory and Clinical Development strategy
Evaluation of possible Regulatory pathways in Japan such as Sakigake, early conditional approval and others
CMC requirements and gap analysis
Forecast and recommendations
Alignment of Japan regulatory strategy with global strategy
Evaluation of suitability of non-clinical, clinical and CMC package for development and registration in Japan 
Registration strategy
Evaluation of different entry options to Japan market
Scientific advice with PMDA including preparation of brief book

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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