Yakumed Limited

YAKUMED is a one-stop consultancy specialized in the Japanese Pharmaceutical and medical Device Markets. YAKUMED is based in England (West of London) with offices in Japan (Tokyo, Osaka) and US (Washington DC) Leveraging our rich experience (30 years plus) and our world-class team of of Japanese experts, we provide first class professional strategic advice and operational support for Pharma/Biotech to develop and register their drugs in Japan. We offer a wide range of services covering regulatory affairs, non-clinical and clinical development, Business Development, Safety and PV, Pricing, Commercial and Distribution strategy and operations. Our clients range from small US/European biotech to large multinational pharmaceutical companies. Our experience spans a wide range of therapeutic areas and technologies including but not limited to Oncology, Immunology, Pain, Neurology, Haematology, Rare Diseases, Regenerative Medicine and Vaccines Our services span a wide range of areas including: 1- REGULATORY AFFAIRS AND DRUG DEVELOPMENT Strategic Advice during development and after product commercialisation PMDA Scientific Advice, CTN, J-NDA, Orphan Drug Designation Clinical Development Pharmaceutical Development: Japan-Specific CMC Requirements KOL Mapping and Interactions Regulatory Intelligence GMP, GCP Audit Preparedness 2-Market Access, Commercial and Business Development Pricing and Reimbursement Strategic Advice Negotiation with MHLW regarding Pricing Commercial and distribution strategies for Japan Marketing strategies and launch preparedness Market Survey to drive robust commercial strategies Business Development and licensing deals Identification of Potential Partners in Japan Negotiation strategies with Japanese pharmaceutical companies In-licensing and Out-licensing deals between Japanese and foreign companies