Orphan Designation
ORPHAN DESIGNATION
THE PROBLEm
Several companies requested our support to obtain orphan designation in Japan.
THE SOLUTION
We supported the company to receive orphan designation in Japan in a short time. Yakumed has prepared and led the regulatory strategy and its execution. We arranged and led the meeting with MHLW, prepared and submitted all the required documents, and responded to queries from MHLW until orphan drug designation is received in Japan.