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


YAKUMED LIMITED

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YAKUMED LIMITED

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