Business Outline

We would contribute for our client companies through the services to develop and propose the most appropriate R&D strategies, for the establishment of clinical development and/or clinical study plans by the R&D institutes (corporate, bio-tech., and the investigators) of pharmaceutical, medical device, and/or regenerative medicine; aiming at obtaining the NDA Approval or MAH Authorization, as well as the services to provide the project management activity.

We would contribute for the Japanese companies that plan for global development, and for the overseas companies that aim at obtaining NDA Approvals or MAH Authorizations in Japan but do not have their Japanese branch or any legal representative in Japan.

• We provide the following services:
  • Consultations for the R&D and/or the business development of pharmaceutical drug product, etc.
    • Consultations for the development of clinical and/or regulatory strategies in the R&D activities
      • Preparations of clinical development strategies and clinical study plans
      • Preparations of regulatory strategies and the supports in the corresponding activities to the regulatory authorities
      • Project management activities
    • Consultations for the development of marketing strategies
    • Other consultations and/or hands-on activities, regarding to clinical studies and regulatory perspectives
  • In-Country Care Taker (ICC) services:
    • Development activities in Japan of the projects that are preceded or already approved in foreign countries
      • Core activities in development works, for the foreign companies that do not possess their Japan branch and/or legal representative
        • Development of Japan domestic development strategies
        • Correspondences for regulatory authorities (MHLW & PMDA)
        • Utilizing other CROs in Japan for the operational works such as CRA/DM/MW etc. for cost efficiency
  • We also welcome private inquiries on the matters, other than mentioned above.  Please feel free to contact us.