Biopharmaceuticals and Gene Therapy
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We cover various aspects of the Japanese Pharmaceutical market
Business culture in Japanese Pharma and Healthcare
Japanese Key Opinion Leaders
Japanese Regulatory Strategy & PMDA consultation
Clinical Trial Notification and CXP compliance
Japan NDA strategy, and execution
Commercial Launch Preparedness
Crisis & Conflict Resolution in Japan
Japan Healthcare Sector Analysis
Business culture in Japanese Pharma and Healthcare
- 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
Japanese Key Opinion Leaders
- 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
Japanese Regulatory Strategy & PMDA consultation
- 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
- Forecast and recommendations
- Evaluation of different entry options to Japan market
- Scientific advice with PMDA including preparation of brief book
Clinical Trial Notification and CXP compliance
- 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 processInteraction with PMDA throughout the CTN process
- Timely response to PMDA queries
- Understand Body Language and communication
- How to succeed in working with Japanese professionals
- Trouble shooting and regular advice and guidance for a smooth CTN
Japan NDA strategy, and execution
- 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
- Understand Body Language and communication
- How to succeed in working with Japanese professionals
- 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
Commercial Launch Preparedness
- 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
Crisis & Conflict Resolution in Japan
- Situation Analysis to delineate fault lines and propose possible solutions
- Immediate action to minimize the damage and implementation of temporary measures
- Mid-Long term implementation plans
Japan Healthcare Sector Analysis
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 on 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.
We cover various aspects of the Japanese Pharmaceutical market
Business Culture in Japanese Pharma and Healthcare
- 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
Japanese Key Opinion Leaders
- 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
Japanese Regulatory Strategy & PMDA consultation
- 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
- Forecast and recommendations
- Evaluation of different entry options to Japan market
- Scientific advice with PMDA including preparation of brief book
Clinical Trial Notification and CXP compliance
- 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 processInteraction with PMDA throughout the CTN process
- Timely response to PMDA queries
- Understand Body Language and communication
- How to succeed in working with Japanese professionals
- Trouble shooting and regular advice and guidance for a smooth CTN
Japan NDA strategy, and execution
- 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
- Understand Body Language and communication
- How to succeed in working with Japanese professionals
- 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
Commercial Launch Preparedness
- 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
Crisis & Conflict Resolution in Japan
- Situation Analysis to delineate fault lines and propose possible solutions
- Immediate action to minimize the damage and implementation of temporary measures
- Mid-Long term implementation plans
Japan Healthcare Sector Analysis
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 on 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.
People Who Love Our Place
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