• Expert Consultancy in the Japanese Pharmaceutical Market

    Licensing - Regulatory - Drug Development - Commercial Strategy

  • Our Mission

    To Maximize Your Product's Opportunities in Japan through:

    Multidisciplinary Team

    Our team is composed of World-Class Experts with 30 + years Japan Experience

    Integrated Robust Strategy

    We cover Regulatory, Drug Development, Licensing and Commercial Strategy

    Flexible & Client-focused

    We are agile with strong focus on our Clients. We cater our services to meet their unique needs

    Excellent Communication

    We are a perfectly Bilingual team with a culturally-sensitive Communication style

  • 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."

      VP of a Top USA Bio-Pharmaceutical Company

      "Excellent and Reliable Services on the Japanese Regulatory and Business Development sides. I highly recommend YAKUMED"

      Sr. Director of European Biopharmaceutical Company

      "YAKUMED provided timely, thorough and relevant local expertise and were very helpful in facilitating the interaction between European and Japanese partners. A pleasure to work with."

      Executive of a Global CRO in USA

      Over the course of the one year-long project, YAKUMED has provided incredible regulatory and product supply expertise ..... The client was especially happy with the level of detail that YAKUMED was able to provide on the requirements .... We consistently found YAKUMED's services to be of very high quality and very professional."

      Senior Executive of a mid-size 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."

    • Meet Our Executive Team

      Our multinational team combines experience with scientific expertise, business creativity, and dedication. Our team works from our two offices and is committed to supporting our global clients .

      Mohamed Oubihi Ph.D

      President & CEO

      • 20 years experience on the Japanese Bio/Pharma field
      • Ex-vice chairman of Japanese Association of Food Additives (Enzyme Division)
      • Strong Experience in Business and Drug Development 
      • Leadership roles at Novozymes, Biogen and Abbvie
      • Advised a dozen of Pharma companies to enter the Japanese market
      • Fluent Japanese-English-French-Arabic

      Hiromu Ozaki

      COO & Yakumed Japan Representative

      • 35 years Pharma/Biotech experience
      • Ex-President of Biogen and Sosei in Japan. Ex-President of Astellas in Canada
      • Board Member of Biocomo
      • Strong Commercial, Corporate Management and Leadership experience
      • Business Development and Licensing Experience
      • Bilingual English-Japanese

      Hidehiro Ando

      VP Licensing & Business Development

      • Over thirty years in the Japanese Pharmaceutical/Biotech Market
      • Ex-Board Member of Stem Cell Science KK, Japan
      • Immaculate Understanding of the Japanese licensing landscape
      • Senior level Licensing experience in several Japanese and Foreign companies including Tanabe Pharmaceutical, Bayer Japan BD and Sosei 
      • Bilingual English-Japanese

      Akihiko Hasegawa

      VP CMC & Regulatory Affairs

      • Over 39 years experience in CMC and Regulatory Affairs
      • Exceptional expertise covering both Medical Device and Pharmaceuticals
      • Ex-Head of Regulatory Affairs and Safety in Schering Japan, Ex-QA Director with Alcon Japan, Ex-Marketing Supervisor General with AstraZeneca and Baxter
      • Author of a dozen Publications in National and Internal Scientific Journals
      • Bilingual Japanese-English

      Hiroshi Tamazawa

      VP Banking and Supply Chain

      • Expert with over forty years in the Japanese Pharma and Banking sectors
      • Ex-General Manager of Marketing at Kinki Osaka Bank
      • Ex-Director Sales and BD in Supply Chain business at Namicos
      • Excellent Knowledge of the Japanese Banking sector
      • Experience covering range of Financial and Business Operations

      Shokichi Kusama

      VP Safety and Pharmacovigilance

      • Over 39 Years Experience in Japanese Safety and Post-marketing surveillance

      • Ex-Head of Japan Drug Safety Department in UCB, Ferring Pharma and Allergan

      • Highly respected Expert on Safety and PMS in Japan

      • Strong interaction and negotiation experience with PMDA/MHLW

      • Bilingual English/Japanese

    • Our Services

      We cover various aspects of the Japanese Pharmaceutical Market

      Partnering, Licensing & Commercial Strategy

      • Identification of Potential Partners in Japan

      • Partnering between Japanese and foreign pharmaceutical companies

      • Advice on the best negotiation strategies with Japanese pharmaceutical companies

      • Assessment of the commercial Opportunity in Japan

      • Marketing and Commercial Strategy

      • Selection and recommendation of the best fit CROs, CMOs and Distributors in Japan

      • Pricing and Reimbursement

      • Market Intelligence

      Market Entry Strategy & Operations

      • Strategic Evaluation of setting an affiliate in Japan

      • Management of Financial aspects of setting a business in Japan

      • Operational support to establish a legal entity in Japan

      • Strategic and Operational Support to obtain Pharmaceutical Business License

      • Establish affiliate structure and interim staff until drug approval and beyond

      • Support the interaction with Hospitals and KOLs

      Regulatory Affairs/CMC/Clinical Development

      • Strategic Advice throughout drug development and post-commercialization

      • PMDA Scientific Advice

      • Regulatory Submissions (CTN, NDA, Orphan Drug Designation, etc.)

      • Clinical Positioning

      • KOL Mapping and Interactions

      • Pharmaceutical Development: Japan-Specific Quality Requirements

      • GMP, GCP Audit Preparedness

      Pharmacovigilance

      • Preparation and Review of Japan specific GVP (Good Vigilance Practice) and GPSP (Good Post-marketing Study Practice) SOPs

      • Assessment and Review of safety documents (Module 1, Module 2, RMP, etc.) for submissions to PMDA

      • Consultation and Interactions with PMDA regarding safety matters

      • Gap Analysis of global documents to meet Japan-specific requirements

      • Strategy and Management of PMS, EPPV, Periodic Safety Reports

      Quality Assurance​

      • Clear and thorough advice on Japan’s unique quality requirements

      • Clarify differences with EU and US quality systems

      • Preparation of the required GQP (Good Quality Practice) SOPs in both English and Japanese

      • Advice on the most up to date Japan-specific GMP requirements

      • Support for Inspection by PMDA and local Governments in Japan

    • News

      Thoughts, musings, and market reflections.

    • Case Studies

      Highlights from ongoing and previous mandates

      Licensing Deal between a large US Biotech and a local Company in Japan

      Licensing

      Yakumed developed a strategy to approach the Japanese market, screened a dozen of local companies based on a systematic analysis of the Japanese market and meetings with potential partners. Finally a couple of companies were shortlisted based on Yakumed's recommendation. The top company in Yakumed's list was eventually selected and a deal was signed. The relationship between both companies is excellent and ongoing.

      Out-licensing deal between A European Pharmaceutical company and a Japanese company

      Licensing

      Yakumed provided a comprehensive strategic assessment to the Japanese market and some of the risks in preparation for the negotiation between two parties. In addition, Yakumed assisted in the face-to-face negotiation with the Japanese partner.

      Approval of CMC variation in a Crisis Situation

      Regulatory Affairs

      A leading US-based company was strugling to obtain approval for a CMC variation in Japan. A delay in approval was going to jeopardize the supply of the new formulation to the patients in Japan. We engaged in a quick but extensive education company to the multidisciplinary team on the regulatory processes and timelines. We also provided the industry benchmark in order to manage the expectations. We provided several contingency plans while staying focused on the preparation of high quality responses to Queries from PMDA in order to secure a quick approval. We were successful in obtaining approval without supply issues.

      Making sense of Conflicting Information on Regulatory and Drug Development Strategy

      Regulatory Affairs

      Some European and American Pharmaceutical companies have been receiving conflicting information on the Japanese regulatory and clinical development pathways. We have carefully assessed each case and provided independent in-depth analyses based on the Japanese regulatory requirements and the scrutiny of precedence in Japan. We have provided a thorough analyses and presented our recommendations. Our detailed assessment reports and follow-up discussions have been useful for these companies to make a decision.

      Formulation Strategy of Investigational Medicinal Product

      CMC Strategy

      An established Pharmaceutical company sought our advice on the CMC formulation strategy for a placebo-control study in Japan. Our team provided scientific regulatory evaluation based on the Japanese requirements and the latest technology advances in this area. Our study was backed by a confidential market intelligence of similar cases. Our advice and recommendations helped the company to implement a global strategy, which aligned Japan with EU and US.

      Orphan Designation in Japan

      Go-To-Market

      Several companies requested our support to obtain orphan designation in Japan. We studied each case and provided strategic advice for the designation in Japan. We also prepared and submitted all the documents needed to MHLW. We have also arranged and led the negotiation with MHLW.

    • How can we help You?

      Yakumed operates globally from its offices in the UK and Japan. To contact us, please complete the form below.

      1210 Parkview Arlington Business Park Theale RG7 4TY
      +44-1189654037
    • 6F Nukariya Building 1-16-20 Minami Ikebukuro Toshima-ku Tokyo 171-0022
      +81 (0) 3-5326-3385
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