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Japan NDA strategy,  and execution

Overall JNDA Strategy including analysis and recommendations
Compilation of all documents necessary for J-NDA
Understand Body Language and communication
Submission of NDA and support during interactions with PMDA to respond to queries and to negotiate with PMDA throughout the process
Gap Analysis of global CTD and highlight parts such M1, M2 and other parts which need to be changed and adapted to meet Japanese requirements 
Submission of NDA and support during interactions with PMDA to respond to queries and to negotiate with PMDA throughout the process
How to succeed in working with Japanese professionals
Lead the strategy and communication with PMDA during such intense period

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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