Offering Services from Basic Research to Practical Applications
CMIC Group has established systems ready to implement and form development strategies and support every stage of the cell & gene therapy / regenerative medicine lifecycle, including regulatory consulting, various nonclinical and clinical studies, and post-marketing. By utilizing our vast knowledge and experience to maximum effect, we offer various services at one stop to fulfill the goal of marketing authorization/sales in regenerative medicine as well as providing the total support our customers need.
Our Edge in Cell & Gene Therapy / Regenerative Medicine
End-to-End Solution in Cell & Gene Therapy / Regenerative Medicine
Support Structure Specializing in Cell & Gene Therapy / Regenerative Medicine
- We have a specialized team of consultants who previously worked for pharmaceutical companies, with years of experience in the cell & gene therapy / regenerative medicine field. These specialized staff have detailed knowledge of pharmaceutical development regulation, providing comprehensive support that is informed by up-to-date knowledge of the latest topics in cell & gene therapy / regenerative medicine.
GxP Compliant Facility
- We offer quality testing of raw material, in-process control testing, and quality control testing of final products under GMP (GCTP)-compliant conditions. Our animal research facility complies with requirements on safety evaluation of cell & gene therapy / regenerative medicine under GLP.
Clinical Development Experience and Capability
- We allocate dedicated resources to support clinical trials and research. We have the expertise to support cell-based products derived from somatic cells, stem cells or iPS cells (autologous and allogeneic), cancer vaccines (cellular immunotherapy), gene-therapy products and oligonucleotides.
Specializing in Japan Market Entry
- CMIC Group provides support for foreign or domestic market entry in Japan, with expertise in navigating Japan’s challenging regulatory environment. Our services include PMDA consultation, Cartagena application for gene therapy using viral vectors, Sakigake designation and Orphan Drug designation.