Japan Entry & NDA
JAPAN ENTRY SET-UP, NDA SUBMISSION AND NEGOTIATION WITH PMDA UNTIL APPROVAL
THE PROBLEm
The US company with no prior experience in Japan needed urgently to set up a local affiliate in order to submit an NDA in Japan before a competitor drug hits the market.
THE SOLUTION
Yakumed has provided the company with deep strategic advice and a creative plan to reach its objectives. On the operational aspects, Yakumed immobilized its seasoned team of experts to set up a local entity in Japan, obtain a Business Marketing License, submit a new drug application, and obtain approval in a short time without impacting the quality of the submission.