Services
We cover various aspects of the Japanese Pharmaceutical market
Market Research and Japan Entry
Japanese Key Opinion Leaders
Orphan Drug Designation
Partnering and Business Development
Japan NDA strategy, and execution
Commercial Launch Preparedness
Business Culture in Japanese Pharma and Healthcare
Japanese Regulatory Strategy & PMDA consultation
Representation in Japan for your company
Clinical Trial Notification and CXP compliance
Market Access
Crisis & Conflict Resolution in Japan
Japan Healthcare Sector Analysis
People Who Love Our Place
Hear what our incredible customers have to say!
Yakumed’s specialized expertise and experience in the rare disease/orphan space has been an enormous resource to help guide and inform our development and regulatory strategies in the Japanese marketplace. Their team is prompt and thorough in their analyses and risk assessments, and their sense of urgency to jump in as situations developed cannot be understated. And of course, having a team with proven track records in key areas /positions that is accessible as such is like having an in-house expert whenever you need one. They continue to be a great partner for me and my team and would recommend them for your company.
- Company size: Over 1000 employees
- Service Category: Orphan Drug Designation and J-NDA
- Location: US
- Position: SVP Global Regulatory Affairs
Our rare disease biotech company was supported by YAKUMED to establish ourselves in Japan. This includes successfully setting up a legal entity, providing temporary staffing of mandatory roles, obtaining a Marketing Business License, supporting the filing of the Japanese NDA and selecting partners for manufacturing/distribution. We enjoy the pleasant and professional collaboration. We highly recommend YAKUMED services.
- Company size: Over 100 employees
- Service Category: Market Entry, PMDA consultation, J-NDA and Launch
- Location: US
- Position: SVP International Commercial
Yakumed group has been very effective in supporting us through the authoring of the module 3 component of the Japanese NDA for our cell therapy product. They were expedient, reliable and with deep expertise in Japanese regulatory requirements. In addition, they showed flexibility in helping us address numerous adhoc strategic issues that were not necessarily related to the agreed to scope of work but were crucial to our regulatory and drug development activities in Japan. I have no reservations in recommending Yakumed as a strong reliable Regulatory Consultancy with deep expertise in Japanese drug development, and I would continue to rely on them as an excellent partner in our product development activities in Japan.
- Company size: Over 100 employees
- Service Category: J-NDA Preparation, PMDA Consultation
- Location: US
- Position: SVP Regulatory Affairs
Yakumed has been an excellent partner with our company acting as a liaison and regional expert in our efforts to identify potential pharmaceutical partnerships in Japan. I have found them professional, responsive, and very knowledgeable about the Japanese commercial market and regulatory Agency. They have extensive contacts in both Japanese pharma and with key medical opinion leaders
- Company size: Over 30 employees
- Service Category: Partnering and KOL engagement
- Location: -
- Position: Ex-CEO Galection Therapeutics