PharmaLex Japan’s step-wise approach begins with literature-based medical research and investigation of regulatory precedents to prepare clinical development strategies that align regulatory and commercial objectives for Japan with the US and/or the EU.
Our team arranges meetings with leading KOLs and coordinates informal interactions with regulators to ascertain preliminary medical and regulatory feasibility of the proposed strategy. Note that a Phase 1 “bridging study” is often a critical element of global development programs for Japan. We provide expert support in developing study designs that will generate the safety, tolerability, and PK/PD data required by PMDA to initiate clinical trials in Japanese patients.