Accessing the Japanese Market
Linical supports Biotech venture/pharmaceutical companies interested in entering Japanese market but unfamiliar with its
regulations and/or those who are seeking for strategic partners to distribute and commercialize their products in Japan.
Our Innovative Drug Development Business (IDDB) includes:
- Patient forecast
- Market value and forecast
- Treatment algorithm and guidelines
- Approved products and major pipelines
- Target product profile
- Price and Sales forecast of the client’s product
Development & Regulatory Strategy/PMDA Consultation/ Medical Writing
- Proposal of development and regulatory strategy.
- Application and preparation of materials for PMDA consultation meeting.
- Presence at PMDA meeting w/wo the client.
- Writing the IB, Protocol and ICF.
- Submission of Clinical Trial Notification.
- In Country Clinical Care-taker.
- Orphan designation registration.
Strategic Partnering/ Licensing
- Search and analysis of potential partners.
- Approach to potential partners and introduction of the client’s product.
- Arranging meetings and mediating communication between the client and potential partners.
- Attendance to partnering conferences w/wo the client.
- Due diligence support.
The Right Team
Our IDDB team have been involved with research, clinical development, medical writing, regulatory affairs, project management, licensing or business development for many years in the pharmaceutical or CRO industry.
Supporting Biotechnology Companies
from the earliest phase of development
Through IDDB, Linical not only supports pharma companies that already have in-house capabilities of clinical development, marketing, licensing and business development, but biotech companies who lack these capabilities, from the earliest phase of development.