YAKUMED is a niche consultancy specialized in the Japanese Pharmaceutical and medical Device Markets. YAKUMED is based in England (West of London) and Japan (Tokyo). Leveraging our rich experience (30 years plus) and extensive network of experts in the Japanese Market, we provide first class professional strategic advice and operational support taking into account the global context of regulatory and drug development. We offer excellent services in the areas of regulatory affairs, pharmaceutical and clinical development, Business Development and Market Research Intelligence. Our clients range from small US/European biotech to large multinational pharmaceutical companies and global CROs and management consultancies. 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 include: 1- REGULATORY AFFAIRS AND DRUG DEVELOPMENT Strategic Advice during development and after product commercialisation PMDA Scientific Advice, CTN, NDA, Orphan Drug Designation Clinical Development Pharmaceutical Development: Japan-Specific Quality Requirements KOL Mapping and Interactions Regulatory Intelligence GMP, GCP Audit Preparedness 2-BUSINESS DEVELOPMENT Pricing and Reimbursement Strategic Advice Business Development Market Pharma Market Research and Intelligence Identification of Potential Partners in Japan Advice on negotiation strategies with Japanese pharmaceutical companies In-licensing and Out-licensing deals between Japanese Universities and foreign companies 3- VENDOR SELECTION AND RELATION MANAGEMENT CRO selection and recommendation, management and support Selection of Contract Research Analytical Laboratories Selection and recommendation of CMOs in Japan