Dr. Manal Morsy (SVP Regulatory Affairs Athersys Therapeutics).
“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.
Senior Director Regulatory Affairs of US-based Biotech Company
“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 to others.”
Dr. Peter G. Traber, Ex-CEO of Galectin Therapeutics (Ex-CMO at GSK)
“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 agencies. They have extensive contacts in both Japanese pharma and with key medical opinion leaders.”
Head of Regulatory Strategy, Pharmaceutical company in Europe
“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.”
Head of International Commercial of US Biotech
“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 enjoyed the pleasant and professional collaboration. We highly recommend Yakumed services”.
CEO of a Start-up Biotech in Europe
“Yakumed has helped us develop a sound regulatory strategy for the Japanese market, and their local knowledge has been invaluable in setting up and preparing meetings with the Japanese authorities. We can warmly recommend their services in this respect.”
Senior Director of European Biotech Company
“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.”
VP of a top USA Bio-Pharmaceutical Company
“Excellent and reliable services on the Japanese regulatory and business development sides. I highly recommend Yakumed”
CEO of a Global Biotech
“Yakumed helped us to quickly understand the Japanese Market Potential for our portfolio of affordable biosimilars. The team was also able to get us in front of the right people so we could determine our Japanese strategy. We recommend their services”
VP of Regulatory Affairs of a US-based oncology Biotech Company
“Yakumed’s 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.”