Full Service CRO
Medical Device Development Services

Total support for entry of foreign medical devices into Japanese market

[Scope of Service]

  • Class I, II, III, IV

[Major Services]

  • Design of effective pharmaceutical affairs strategies for obtaining license for marketing authorization holder, license for manufacturing, and accreditation of foreign, etc.
  • Support for the application of Approval / Certification / Registration
  • Consulting, preparation of documents for application, corresponding to PMDA or third party certification body, feasibility study of foreign clinical data and others.
  • GCP Audit of overseas/local clinical trial data and preparation of audit report (English available)
  • Operation of local clinical trial and post-marketing surveillance.
  • Preparation of clinical evaluation report
  • Clinician and co-medical interview

Example: Our Support Process for Application of foreign Medical Device

Our priority is to actively use the Foreign Clinical Trial Data for cost reduction.