About Regulatory Consulting

Focusing on Regulatory Consulting, our consultants provide support from compilation of strategic development plans to marketing approval for drugs, regenerative, cellular therapy and gene therapy products, , medical devices, and in-vitro diagnostics (IVD).
Our consultants leverage their deep expertise and know-how in the respective specialties and form well-balanced teams to ensure the success of projects.

  • Our specialists in pharmaceutical affairs with rich experience spanning across development, regulations and CMC, and development of drugs, regenerative medicine products, etc. and medical devices leverage their expertise in their respective fields to generate value. Our regulatory consultants are exposed to the latest advancement in science, technology and therapeutic needs both in Japan and overseas, and through leveraging regulatory sciences and providing trustworthy services, they actively contribute to the development of curative and therapeutic services and the healthcare field.

Scope of Work Scope of Work

    • Support through the entire process from compilation of strategic development plans to marketing application submission and approval
    • Assistance related to various pharmaceutical affair applications
    • Preparation and review of related documents that accompany applications
    • Liaise with regulatory authorities such as the PMDA (Pharmaceuticals and Medical Devices Agency)
    • Support on CMC matters
    • Consulting on drug pricing strategy and reimbursement
    • Consulting on outbound expansion to overseas countries, Japan market entry and more
  • We have abundant consulting experience in such areas of drugs, regenerative , cellular therapy and gene therapy, medical devices, in-vitro diagnostics (IVD), etc.

Skill Required Knowledge and Skills

  • Expertise and know-how in any of the following: development pharmaceutical affairs, drug regulatory affairs, CMC pharmaceutical affairs, pharmaceutical drug development, regenerative medicine, product development, medical device development, and in-vitro diagnostics (IVD) development.
  • Knowledge in pharmaceutical regulatory affairs and relevant ministerial notifications, etc. and experience of working with regulatory authorities
  • Leadership
  • Communication skills
  • Logical thinking
  • Multitasking skills
  • Flexibility and English ability to interact with global counterparts

Skill Knowledge and Skills gained on the job

  • Expertise in diseases, pharmaceutical regulatory affairs, legislation, etc.
  • Global leading-edge information and knowledge
  • Management skills
  • Communication skills
  • Problem-solving ability

Data Data

  • Academic background



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As of March 31, 2023