After reaching consensus with a client on a development strategy, PharmaLex Japan works to gain endorsement of a proposed approach through formal interactions with PMDA.
PMDA issues official written endorsements of development strategies through a well-established and transparent consultation system that provides clarity and assurance regarding viability of a specific regulatory pathway towards approval and marketing in Asia’s pharmaceutical market. Our team navigates these regulatory complexities with clients to harmonize development approaches for PMDA.