Regenerative medicine and cell therapy

Using our collective strengths, we offer a broad range of services from basic research to practical application.

CMIC group, as a pioneer of CROs in Japan, has been providing support for the development, manufacture, and marketing of pharmaceutical products since its foundation. By utilizing the vast knowledge and experience that it has cultivated to maximum effect, CMIC offers various services at one stop to fulfill the goal of marketing authorization/sales in regenerative medicine as well… providing a “Total Solution of Regenerative Medicine.”

 
 

One stop service in regenerative medicine/ cell therapy areas

 

From early stages to postmarketing
We have an established system necessary to implement and form development strategies and support every stage of lifecycle of regenerative medicine, including regulatory consulting, various nonclinical and clinical studies, manufacturing and postmarketing.
CMIC group utilizes its collective strengths to meet the various demands of the client in a swift and flexible manner.


Support structure specialized in regenerative medicine
At CMIC group, we have been engaging in the field of regenerative medicine for a long time to meet the highly specialized demands of this field.
We have launched a specialized team of consultants consisting of members who have previously worked for pharmaceutical companies, PMDA, and have over 10 years of experience in the regenerative medicine field.
Specialized staff with detailed knowledge of regulations of pharmaceutical development who is up to date with the latest topics will offer comprehensive support.

Consultant:Regenerative Medicine and Tissue Engineering

 

List of Services

Regulatory Consulting Services

Development of strategic plan, Regulatory consulting, PMDA consultation, Investigational New Drug, Support for Marketing Authorization Application

Consulting Experience in Regenerative medicine and cell therapy
Over 100 tasks up to 2018

Cell-based products derived from somatic cells, stem cells or iPS cells (autologous and allogeneic), cancer vaccines (cellular immunotherapy), gene-therapy products and nucleic acid drugs 

 
  

Clinical Trial / Clinical Research (clinical development support)

Monitoring, Data management, Statistical analysis, Pharmacovigilance, Project management, Investigational product management, Medical Writing (CSR), Quality assurance

 

Site Management Organization (SMO)

Support clinical sites prepare, execute and operate clinical trial / clinical research

Patient recruitment

Web&insertion, Events about health, Targeting with databases, Trial volunteer panel, Clinical trial/ healthcare portal site, Contact center, etc. 

Post Marketing Surveillance & Clinial Usage Reporting

Monitoring, Data Management, Statistical analysis, Pharmacovigilance, Medical writing

Contract Sales Organization (CSO)

Support commercial operation and provide Medical Affairs solutions

Call Centers

Drug information,Medical equipment support, Disease enlightenment, Patients support, Health consultation, Dealing with recall etc.

Quality tests

Raw material testing, in-process control testing and quality control testing of final products under GMP (GCTP) - compliant conditions: Sterility test (membrane filtration method, direct inoculation method), Endotoxin test (JP17: kinetic assays (colorimetric or nephelometric), gel-clot method), Mycoplasma test (JP17: NAT method using qPCR), Residual test for antibiotics and growth factors (LC/MS/MS, ELISA), Test method validations, etc.

 

Non-clinical safety tests

General Toxicological study and Tumorigenicity study using immune-deficient mice, In vitro tumorigenicity (Soft agar colony formation assay), Cell growth analysis and Efficacy study

Regenerative medicine(Quality assurance tests / Non-clinical safety tests)

  

Manufacture / Storage / Transportation (outsourced)

By forming a partnership with MEDINET Co., Ltd. who possesses the largest cell processing facility (CPF), we have the capability to assist in the development and manufacture of investigational cell products and regenerative medicine products (CDMO).

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Inquiries about our services

Click here if you are interested in outsourcing your operations to us.

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