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Consultations for industry and academia

Consultations for industry and academia

Gene and cell therapy at the NCCHD

  • Clinical trials and practices
  • Post-marketing surveillance and clinical research
  • Genetic counseling and support for patients undergoing gene and cell therapy

Regulations for Gene and cell therapy

  • Compliance with the Cartagena Act, GMP/GCTP, and GCP
  • Assistance for creating a gene and cell therapy protocol
  • Assistance for response to Pharmaceuticals and Medical Devices Agency consultation


  • Development of a new vector and model animals
  • Proposal of quality control tests (including specification tests) and safety and efficacy assays
  • Consultation for clinical trials
  • Practice in a clinical setting
  • Preclinical trials
  • Cooperation between Japanese academic societies

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