CMIC CMO USA Corporation
CMIC is a leading provider of pharmaceutical and healthcare solutions, including contract research organization (CRO) services, contract development and manufacturing (CDMO), healthcare support, and digital healthcare platforms. With a mission to bring innovation to healthcare and improve patients' lives, CMIC operates globally with a focus on Japan, the US, and Asia. The company emphasizes sustainability, diversity, and compliance with regulations such as GDPR, and is committed to ethical business practices, environmental management, and social contribution activities. CMIC supports active clinical trials across more than 13 countries in the APAC region, leveraging a vast network of over 4,000 clinical sites, and is the first CRO in South Korea with experience in over 600 studies. The company also offers a broad range of services supporting the entire pharmaceutical value chain, from pre-clinical studies to market solutions, and has a strong focus on innovation, compliance, and corporate governance.
Industries
Nr. of Employees
large (251-1000)
CMIC CMO USA Corporation
Hoffman Estates, Illinois, United States, North America
Products
Urinary biomarker assay kit for early diagnosis of kidney disease
A diagnostic assay kit for urinary biomarkers intended to support early diagnosis of kidney disease.
Orphan drug treatments and acquired orphan drug supply
Provision and commercialization support for orphan drugs for rare diseases, including regulatory filing and supply activities in Japan.
Urinary biomarker assay kit for early diagnosis of kidney disease
A diagnostic assay kit for urinary biomarkers intended to support early diagnosis of kidney disease.
Orphan drug treatments and acquired orphan drug supply
Provision and commercialization support for orphan drugs for rare diseases, including regulatory filing and supply activities in Japan.
Services
Non-Clinical Studies
Preclinical safety, efficacy and genotoxicity studies and GLP-compliant testing to support IND/clinical development.
Clinical Studies
End-to-end clinical development services from Phase I through Phase IV, including site management, monitoring and data analysis.
Consulting (Strategic and Regulatory)
Regulatory strategy, product life-cycle management, Japan market entry research and regulatory affairs consulting.
Contract Development & Manufacturing (CDMO)
Formulation and process development, investigational and commercial GMP manufacturing, packaging and commercial supply services.
Post-Market Surveillance
Post-approval safety monitoring and market surveillance activities to maintain product safety profiles.
Commercial Supply
Support for commercial production and distribution of pharmaceutical products.
Non-Clinical Studies
Preclinical safety, efficacy and genotoxicity studies and GLP-compliant testing to support IND/clinical development.
Clinical Studies
End-to-end clinical development services from Phase I through Phase IV, including site management, monitoring and data analysis.
Consulting (Strategic and Regulatory)
Regulatory strategy, product life-cycle management, Japan market entry research and regulatory affairs consulting.
Contract Development & Manufacturing (CDMO)
Formulation and process development, investigational and commercial GMP manufacturing, packaging and commercial supply services.
Post-Market Surveillance
Post-approval safety monitoring and market surveillance activities to maintain product safety profiles.
Commercial Supply
Support for commercial production and distribution of pharmaceutical products.
Expertise Areas
- Clinical trial management
- Non-clinical toxicology and safety pharmacology
- GLP bioanalysis and biomarker assays
- CMC and GMP manufacturing for clinical and commercial supply
Key Technologies
- GLP-compliant bioanalytical testing
- GMP manufacturing for biologics and small molecules
- Formulation and process development
- Release and stability testing