Your Partner for Success
in Japan

• 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

• Introduction to the Japanese culture
• Historical and Philosophical aspects and how they shaped Japanese psyche and business
• Unique Japanese cultural considerations
• Japanese Business Culture
• Understand Body Language and communication
• How to succeed in working with Japanese professionals

• Identification and Selection of Japanese KOLs. Development of communication and engagement strategies and plans to work with KOLs.
• Working with KOLs to understand the unmet need, the medical practice in JP and the Clinical positioning of the drug in Japan
• How to avoid pitfalls in working with KOLs
• How to leverage the support of KOLs for a successful PMDA consultation
• How to leverage KOL support for an effective clinical development and commercial success

• Regulatory and Clinical Development strategy
• Alignment of Japan regulatory strategy with global strategy
• Evaluation of possible Regulatory pathways in Japan such as Sakigake, early conditional approval and others
• Evaluation of suitability of non-clinical, clinical and CMC package for development and registration in Japan
• CMC requirements and gap analysis
• Registration strategy
• Scientific advice with PMDA including preparation of brief book

• We provide full support to obtain orphan drug designation in Japan
• Robust strategy for ODD including risks and mitigation measures
• Lead Consultations with MHLW and interaction until designation is received
• We also support process of obtaining funding from the Japanese government

• For companies which do not have an affiliate in Japan, representation in Japan as In-country care taker. Yakumed will represent you in communication with PMDA, MHLW and other stakeholders.
• Support on all areas related to your clinical development, regulatory affairs, Orphan drug designation, business development and other areas.
• Support in setting up a business affiliate in Japan as Marketing Authorization Holder (MAH)

• 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 understanding the market dynamics and the real value of your asset in Japan. We help you avoid gaps of communication and cultural conflicts.

We provide a wide range of services related to Clinical Trial Notification (CTN):

• Selection and recommendation of cost-effective CROs for running your clinical trial in Japan
• Preparation, review and submission to PMDA of all documents required for CTN
• Interaction with PMDA throughout the CTN process
• Timely response to PMDA queries
• Trouble shooting and regular advice and guidance for a smooth CTN

GCP compliance in Japan
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 in Japan
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)

• Overall JNDA Strategy including analysis and recommendations
• 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

• Supply Chain analysis including compliance with local requirements, selection of potential CMOs, negotiation, technology transfer
• Distribution in Japan, which includes introduction to the distribution dynamics in Japan, OTC strategy development, recommendations with regards to the suitable wholesalers and 3PL.
  Daily support to prepare RFPs, contracts, negotiations and set up process for whole commercial operations.
• Marketing Business License (MBL) is a prerequisite before JNDA submission. We provide strategic and operational leadership to obtain MBL. This is a key requirement for a company to become a marketing authorization holder MAH) in Japan
• Marketing strategy (conferences, website set-up, recruitment of MR ) and operations.
• Selection of vendors for safety management post-approval
• Organize and Management of KOL board meetings

We recommend early and thorough preparation when entering Japan market, however we recognize that it is practically impossible to avoid unexpected crises throughout the development, registration and commercial journey in Japan. We have supported numerous companies going through such difficult moment. Our team of experts are in a great position to share their insights to solve the most sensitive issues in all confidentiality.

Our approach covers several layers: 1) Situation Analysis to delineate fault lines and propose possible solutions, 2) Immediate action to minimize the damage and implementation of temporary measures, 3) Mid-Long term implementation plans

Japanese healthcare is huge, complex and constantly evolving. There are many players with conflicting interests and agendas. The wider economic, political and demographic context has a strong impact on the market dynamics. Keeping abreast of the current and anticipating upcoming potential changes is vital for pharmaceutical companies, service providers and other players interested in the Japanese healthcare sector.

Our sector analysis reports provide deep insights into the building blocks, the intricate connectivity between its different components and what lies in the horizon in terms of possible policy changes and the impact on Japanese healthcare as a whole.