Japan Entry Strategy
Our services
Market Research and Japan Entry Assessment
Understanding Japan Business Culture Mindset
KOL Outreach
Regulatory Strategy & PMDA consultation
Market Research and Japan Entry Assessment
- A detailed analysis based on interview with Japanese investigators and desk top analysis
- Epidemiological analysis of the disease and indication
- Treatment paradigm and market segmentation
- Regulatory analysis
- Market access analysis
- Product positioning
- Forecast and recommendations
- Evaluation of different entry options to Japan market
Partnering with Japanese companies
We have Demonstrated experience in deal-making between Europe/US and Japanese companies.
We provide strategic leadership and operational support to identify and select best-fit potential partners in Japan.
We provide full support and facilitation throughout the whole process (from initial interactions, due-diligence and negotiations) until a deal is signed between both parties.
We increase the chances of success by helping you avoid gaps of communication and cultural conflicts.
We provide full support to obtain orphan drug designation in Japan
We also support process of obtaining funding from the Japanese government
Robust strategy for ODD including risks and mitigation measures
Lead Consultations with MHLW and interaction until designation is received
Clinical Trial Notification, CGP, GLP and GMP compliance inspection Support
We provide a wide range of services including selection and recommendation of cost-effective CROs for running your clinical trial in Japan, the review, preparation and submission of all required documents for CTN
- Interaction with PMDA throughout the process
- Timely response to PMDA queries
- Trouble shooting and regular advice and guidance for a smooth CTN
GCP compliance
Our support for GCP compliance in Japan includes a wide range of services:
- Design and preparation of annual audit plan for Japan and provision of regular GCP compliance advice
- Preparation for PMDA inspection and onsite management at both trial sites and sponsor sites
- Support during GCP audits for trial sites
- Lead and support pre-inspection site visits for PMDA inspections in Japan
- Manage reporting and negotiation with PMDA and MHLW on GCP violation issues
GLP compliance
Gap analysis on GLP requirements in Japan
Support for Data reliability inspection for PMDA
Creative solutions to meet PMDA requests on GLP compliance
GMP compliance
Our support for GMP compliance in Japan includes the following areas among others:
- GMP Evaluation and analysis
- Plan for inspection and improvement
- Education and guidance to company staff on GMP requirements and changes
- GMP Document Management System
- Establishment of GMP system (SOPs and standards)
JNDA strategy and execution
Gap Analysis of global CTD and highlight parts such M1, M2 and other parts which need to be changed and adapted to meet Japanese requirements
- Compilation of all documents necessary for J-NDA
- Submission of NDA and support during interactions with PMDA to respond to queries and to negotiate with PMDA throughout the process
- Lead the strategy and communication with PMDA during such intense period
Market Access
- Explore various options for early access to Japan
- Assessment of pricing and reimbursement for potential pricing early in development
- Strategies to optimise National Health Insurance pricing and reimbursement
- Preparation and submission of all required pricing documents to the Economic Division of MHLW
- Negotiation with MHLW on pricing negotiations
- Support on any other related or follow-up activities
Launch Preparedness, Marketing, Sales & distribution (Wholesalers and 3PL)
Our impact on the patients
We have proudly contributed to improve the lives of patients with the following diseases
Desease 1
300,000 patients cured
Desease 2
300,000 patients cured
Desease 3
300,000 patients cured
Desease 4
300,000 patients cured
Desease 5
300,000 patients cured
Desease 6
300,000 patients cured
We have supported numerous companies in Europe and USA
We have supported numerous companies in Europe and USA to break into the Japanese Pharmaceutical market. We leverage our in-depth experience to ensure new entrants are equipped with the strategic insights to plan effectively and optimize the timing and method of entry.
Yakumed has developed a balanced risk-based approach
- Managing risks and potential damage to a new entrant’s reputation
- Cost-saving strategies
- Managing risks related to regulatory/government policy/pricing etc.
- Stepwise and seamless transition to successful organization
We provide full support for affiliate set up. This includes the following aspects:
- Overall entry strategy
- Operational Management Support
- Trouble shooting and crisis management
We are your gateway for success in Japan
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