BIC Diagnostics Business Consulting offers wide-range expert support services to the Diagnostics (reagents, instruments, software & services) clients.

Our professional experience and expert knowledge allow us to tailor our services to the specific needs of our Diagnostics clients. So please contact us to learn how BIC could be a value addition to your business in Japan and the APAC Region.

Please feel free to contact us to speak to one of our expert consultants.

Focus Areas:

  • Personalized Medicine (PM)
  • Cancer Diagnostics
  • Companion Diagnostics (CDx)
  • Molecular Diagnostics (MDx)
  • Diagnostic Systems

Designated Marketing Authorization Holder (DMAH) services

BIC has First-Class (allowed to handle all classes ) Marketing Authorization Holder (MAH) licenses and Manufacture licenses (Packaging, Labeling and Storage) of Medical Devices and IVDs, which allow us to represent wide range of our client’s products in Japan.

Consulting Services include:

  • Research & Development
  • Selecting and Contacting Clinical Trial Sites, MDs, KOL
  • Regulatory, QA, QC Management
  • Pricing/ Reimbursement
  • Manufacturing
  • Commercialization (Product Management, KOL management, Sales/Marketing Strategies, Distributor/Wholesaler Search and Management)
  • Operations
  • Merger  &  Acquisition, Due Diligence

Meet our Diagnostics leadership team

Katsutoshi (Casey) Obata
Managing Consultant

Read Bio

Casey is an experienced leader in the diagnostics business in Japan. He has held executive positions in global diagnostic companies. Most recently, he established Japan subsidiary of Cepheid a US –based molecular diagnostics company where served as CEO for 3 years. Prior to Cepheid, he served as CEO of Dako Japan a Danish cancer diagnostic company (now Agilent) for 16 years. He also held management positions in American Hospital Supply / International Reagents (AHS/IRC) and HONDA Motors.

He received his bachelor’s degree in Science and Technology from Keio University. He is responsible for delivering solutions to BIC Diagnostics clients.

Our Work / Case Examples

    • Development and Maintenance of Cortellis Regulatory Intelligence database – Clarivate Analytics (present)

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