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Premier Global Resource For Japan-US Life Science Consulting 日米ライフサイエンスの専門家会社
Key Leaders
Keiji Asada （朝田圭司） : CEO/President
Christian Friese: Market Strategy Specialist
Christian Friese: Market Strategy Specialist
- Unique combination of technical expertise (QMS, FDA submission, and clinical software validation) and culture backgrounds have provided clients with successful tactical and strategic solutions
- 15+ years of CRO and Consulting experience
- Bilingual Expertise (Japanese/English)
Christian Friese: Market Strategy Specialist
Christian Friese: Market Strategy Specialist
Christian Friese: Market Strategy Specialist
- Global commercial strategy
- Franchise strategy and portfolio strategy
- Oncology drug specialize
- Bilingual (German/English)
Yurika Baba: Translation (Japanese/English) Specialist
Yurika Baba: Translation (Japanese/English) Specialist
Yurika Baba: Translation (Japanese/English) Specialist
- Professional translator specific to FDA Quality System Regulation (“QSR”), EU Medical Device Directive (“MDD”), and the ISO 13485 standard
David Gorky: Regulatory and Compliance Specialist
Yurika Baba: Translation (Japanese/English) Specialist
Yurika Baba: Translation (Japanese/English) Specialist
- Started 3 separate medical device companies
- Medical Device Regulatory and Compliance specialist
- Over 30 years of experience in the industry
Mason Diamond, DDS: Regulatory and Quality Specialist
Henry Alder: Reimbursement & Health Economics Specialist
Henry Alder: Reimbursement & Health Economics Specialist
- Has drafted and filed submissions for FDA and EU approval of a new manufacturing site for a medical device.
- Supported QA initiative to develop device documentation to maintain compliance with new FDA Combination Product Regulations.
- An FDA Foreign Drug Cadre Investigator conducting GMP and Pre-Approval inspections of API manufacturing dr
- Has drafted and filed submissions for FDA and EU approval of a new manufacturing site for a medical device.
- Supported QA initiative to develop device documentation to maintain compliance with new FDA Combination Product Regulations.
- An FDA Foreign Drug Cadre Investigator conducting GMP and Pre-Approval inspections of API manufacturing drug firms and control laboratories in India, China, United Kingdom (Northern Ireland, Scotland, and England), Ireland, Austria, and France.
Henry Alder: Reimbursement & Health Economics Specialist
Henry Alder: Reimbursement & Health Economics Specialist
Henry Alder: Reimbursement & Health Economics Specialist
- More than 20 years' experience resolving medical device company issues related to reimbursement such as lack of coverage for new technologies and inadequate payment.
- Experience includes developing & executing payer marketing strategies, as
- well as identifying the clinical and economic evidence medical technology companies need to bring to h
- More than 20 years' experience resolving medical device company issues related to reimbursement such as lack of coverage for new technologies and inadequate payment.
- Experience includes developing & executing payer marketing strategies, as
- well as identifying the clinical and economic evidence medical technology companies need to bring to healthcare payers, employers and other stakeholders to obtain insurance coverage and appropriate payment for their new products.