Your One-Stop Partner for Market Access Strategy
At Depew, we have built strong networks with many pharmaceutical companies in Japan and the United States. Building on this foundation, we support global innovative biotech companies entering the Japanese market and helps Japanese biotech companies expand into the U.S. Whether you're looking to in-license innovation or out-license your assets, we help connect you with the right partners.
Depew provides comprehensive support across all stages, including regulatory coordination, clinical trial oversight, business development, and deal negotiation. We work closely with you as an integrated part of your team.
We are not just an introducer.
We are your Strategic Partner.
Regulatory and Clinical Strategy
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.
Local Clinical Trial Support
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.
Business Development & Licensing
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.
Cross-Border Project Management
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.