Pharmaceuticals - London, England, United Kingdom
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 VaccinesOur services include:1- REGULATORY AFFAIRS AND DRUG DEVELOPMENTStrategic Advice during development and after product commercialisationPMDA Scientific Advice, CTN, NDA, Orphan Drug DesignationClinical DevelopmentPharmaceutical Development: Japan-Specific Quality RequirementsKOL Mapping and InteractionsRegulatory IntelligenceGMP, GCP Audit Preparedness2-BUSINESS DEVELOPMENTPricing and Reimbursement Strategic AdviceBusiness DevelopmentMarket Pharma Market Research and IntelligenceIdentification of Potential Partners in JapanAdvice on negotiation strategies with Japanese pharmaceutical companiesIn-licensing and Out-licensing deals between Japanese Universities and foreign companies3- VENDOR SELECTION AND RELATION MANAGEMENTCRO selection and recommendation, management and supportSelection of Contract Research Analytical LaboratoriesSelection and recommendation of CMOs in Japan
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