We provide regulatory and clinical strategy support across all stages of drug development. Our services include regulatory planning, agency communication, clinical trial design and oversight, expedited regulatory pathway evaluation and application, and submission preparation. We support interactions with the FDA and PMDA, help engage and oversee local CROs, and ensure that clinical operations and regulatory activities stay on track.

We assist clients in identifying a suitable local CRO and provide ongoing coordination and oversight throughout the clinical trial. Our support includes translation and cultural adaptation of study documents, as well as regulatory tracking and communication during the study execution phase.

We offer complimentary initial business development support for both global biotech companies entering Japan and Japanese biotech companies seeking international expansion. Beyond the initial support, our full services include identifying and approaching strategic partners, supporting licensing and investment discussions, and assisting with contract finalization and post-deal implementation.

We serve as a bilingual project management bridge between Japanese and global teams, helping clients overcome language and cultural barriers. Our role includes aligning project timelines and quality standards, and ensuring clear communication and mutual understanding of regulatory expectations across regions.