Client Testimonial

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

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

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.

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

I have worked with Yakumed over the year to assess proposed development programs and define regulatory strategy for Japan. YAKUMED has been extremely professional and supportive in providing information and advice that is reliable, useful and on time

Yakumed has provided our company with an in-depth and thorough analysis of the CMC requirements in Japan for both approved and investigational drugs. Their services are excellent and reliable. I highly recommend YAKUMED

YAKUMED provided timely, thorough and relevant local strategic expertise and were very helpful in facilitating interactions between European and Japanese partners during a Licensing deal. A pleasure to work with.

I have been working with Yakumed for the past year through an EOP2 interaction with the PMDA on a biologic being developed in several oncology indications. Our team has benefited greatly from Yakumed’s team of experts during the preparation for the meeting as well as interactions prior to and after the meeting. We will continue to rely on Yakumed’s expertise for future interactions as well as analysis of the evolving regulatory landscape in Japan, especially in oncology. I would recommend Yakumed’s services

Yakumed team worked within a short timeframe to provide my company with a thoroughly researched strategic and competitive regulatory analysis for our program and effectively participated to a meeting with Japanese key opinion leaders. We recommend their services.

I wanted to thank Yakumed for their advice and guidance. They have helped reframe our thinking about our commercial opportunity through the lens of a Japanese partner, which then influenced our approach to the business case, and which culminated with a licensing agreement with the Japanese partner. I hope that there will be other opportunities for us to work with Yakumed in the future. I wanted to express my gratitude to Yakumed.

Yakumed helped us quickly understand the Japanese Market Potential for our pipeline portfolio of products. The team was able to get us in front of the right people, companies and determine our Japanese market strategy.

When establishing a new pharma startup in Japan, it is important to setup an organization with the triangle structure RA, QA and PV in place. Unfortunately, it is very difficult to find such qualified people, willing to take risks in a new venture or retain them, if things do not go as smoothly as anticipated. Yakumed helped us to quickly refill and setup a compliant Triangle organization with highly experienced and senior experts who knew exactly was needed at the time. The flexibility of Yakumed for short and medium-term contracts helped us to look for long-term solutions at our own pace and without the pressure to take the next available person into the organization. I owe Yakumed the compliant survival in very difficult situations and I am very grateful and thankful for that. In addition, it is a pleasure to work with them

Yakumed provided an in-depth strategic assessment for entry into the Japanese market. Their analysis, which was extremely well researched, outlined not only the regulatory pathways in Japan but also provided a full assessment of the therapeutic area and competitors. Yakumed were professional throughout the process and delivered on time, providing a valuable reference resource that will no doubt be used for some time to come. We strongly recommend them for Japan regulatory support

Yakumed provided a critical overview of the Japanese Rare Disease market and helped us benchmark peer organisations to inform our company’s Japan market entry strategy. The data and the detailed analysis provided by Yakumed were excellent. It helped us determine a very clear path forward.

Yakumed’s team took the time to understand our needs, and then rapidly delivered a comprehensive, and actionable regulatory strategy for our lead program. They are a pleasure to work with.