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

Others

• 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