Vorpal Technologies is a trusted brand that specializes in providing expert solutions across various areas, including opportunity assessment, clinical development, regulatory affairs, reimbursement, quality and safety management, supply chain, and commercialization. Our team consists of highly experienced professionals who are passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape. At Vorpal Technologies, we offer a wide range of services to support your needs.

Our services include regulatory and reimbursement strategy, PMDA negotiations and submissions, product assessment, market research, health economics, and market access. We also provide designated marketing authorization holder (D-MAH) services, as well as import and sales of medical devices and in-vitro diagnostics. Additionally, we conduct post-marketing surveillance (PMS) studies to ensure the safety and efficacy of medical products.

Our team is led by Samuel Pollard, our Representative Director and General Manager, who has over a decade of experience in biomedical research and the regulatory/clinical space. Assisting him is Shinichi Tsugawa, our Vice President of Regulatory & Clinical Affairs, with more than 20 years of expertise in the regulatory, reimbursement, clinical, and quality sector. We also have Hiroshi Ichinose, our Director of Regulatory Affairs, who has extensive experience in R&D at a Japanese pharmaceutical company.

For those looking for top-notch quality management, Mari Teshirogi serves as our Director of DMAH QA Manager (Hin Seki), and Hiroshi Torikai oversees the Safety Management department as our Director of DMAH SA Manager (An Seki). Finally, Yumi Yamamoto, our Director of Project Management Ops, ensures the smooth running of projects and client engagement. With Vorpal Technologies, you can trust that you are in capable hands.

We pride ourselves on our expertise, professionalism, and commitment to helping you succeed in the Japanese market