Values
- Time and cost effective development strategy
- Japan market’s simultaneous application and approval became more realistic
Difference
- Flexible business procedure for company no affiliate in Japan
- Working as a hub of operation
- Quality and flexibility on decision making
- Transform to innovative thinks in technology,strategy andoperation in drug development in Japan
- Out of box thinking provides extra value
- Focus on niche market and pediatric drugs
Service of Clinical Operation
Management
- Working together with clients to build clinical development strategy
- Risk management of clinical operations such as,
- Selection of Investigators, Sites, Vendors
- Oversight of clinical operation for quality and timeline
- KOL management including KOL identification and
relationship management, etc.
Service of Regulatory Affairs
- Working together with clients to build regulatory development strategy
- Preparing and submitting high quality regulatory documents,including PMDA consultation package, Clinical Trial Notification(CTN) package, etc.
- Working seamlessly with clients so to facilitate PMDA consultation process
- Acting as clients’ local regulatory representative during the entire process dealing with regulatory authorities
- Utilizing our experience and expertise to establish and implement