Values Icon


  • Time and cost effective development strategy
  • Japan market’s simultaneous application and approval became more realistic

Difference Icon


  • 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

  1. Working together with clients to build clinical development strategy
  2. 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

  1. Working together with clients to build regulatory development strategy
  2. Preparing and submitting high quality regulatory documents,including PMDA consultation package, Clinical Trial Notification(CTN) package, etc.
  3. Working seamlessly with clients so to facilitate PMDA consultation process
  4. Acting as clients’ local regulatory representative during the entire process dealing with regulatory authorities
  5. Utilizing our experience and expertise to establish and implement


  • 2018.03.30

    Our website has recently been renewed.