• To conduct audits for clinical investigation as well as its medical institutions (Investigator) and contract research organizations (CRO)
  • To provide advice of GCP conformity inspection.
  • GMP field

    • Due diligence regarding the GMP regulation for pharmaceutical product factories (Examination・Audit)
    • To instruct site improvement including FDA support
      We support submission of English reports.


    We provide specialized information regarding pharmaceutical regulations of GMP, GQP, GVP, GLP and GCP for domestic and overseas pharmaceutical companies. Also, we develop quality system and provide QA services of pharmaceutical audit.

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    Involving in Project

    Outsourcing companies may have issues of research and development, establishment of quality control system for overseas companies as well as implementation of computer validation. We support to solve those issues through involving in the projects and individual consulting, etc.

    With abundant experiences of research and development, pharmaceutical audit as well as international experiences and knowledge, we are able to participate in a variety of project in the company as an expert. Especially if you have a project under consideration in the field blow, please consult with us.

    • Research and Development
    • Quality control framework establishment for each sector (for overseas)
    • Computer system validation implementation

    Consulting fee