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Strategic and Regulatory Consulting

Strategy and development consulting, regulatory affairs and Japan market research/feasibility
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Non-Clinical CRO Solutions

Bioanalysis, CMC and GMP Analytical Testing, Safety Pharmacology, Toxicology and Efficacy Studies
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Clinical CRO Solutions

Clinical development from Phase I to Phase IV clinical studies
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Site Management Solutions

Study coordinator, site administrator and patient recruitment
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CDMO Solutions

Preformulation study, formulation & process development, investigational product manufacturing and commercial supply
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Sales and Marketing

Sales team establishment, sales staff dispatch and remote communication support
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Patient Support Services

Call center and drug adherence support program
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Healthcare Digital Platforms

PHR for prescription drug, vaccination and symptoms
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Animal Health

Digital platform focusing on epilepsy treatment for pets
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Japan Market Entry

Full pharmaceutical capablities for overseas business partners to enter into the Japan Market
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Asia Clinical Trials

Supporting our client’s clinical trials throughout the Asia Pacific region in more than 13 countries
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Orphan Drug

Regulatory affairs, supply chain management, quality assurance, pharmacovigilance, sales and marketing
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Oncology Drug Development

Strategic development planning, clinical trials, manufacturing and commercialization
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Cell and Gene Therapy

Regulatory consulting, nonclinical and clinical studies and post-marketing
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Medical Devices & IVD

Consulting on regulatory affairs for the latest medical devices and in vitro diagnostics (IVD)
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Your Trusted Service Partner for the US, Japan and Asia

Click to view our global locations, filters by location and/or service.

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Explore our Services by Geographical Location

Involved in nearly 80% of new drug development in Japan
Connected with 4,000+ clinical sites in Asia-Pacific
Among the top 3 Largest CDMOs in Japan, CMIC
15+ years of continuous commercial manufacturing and drug development in the US
2nd Largest CSO in Japan with over 750+ sales reps, nurses and MSLs
Involved in nearly 70% of new oncology drug development in Japan
Completed 400+ oligonucleotide assays in the USA
150+ largest regulatory consulting and medical writing team in Japan with 150+ experts
Largest CRO in Japan
The Only CRO in Japan with CMC, Bioanalysis and non clinical services
600+ graphic featuring the first CRO in South Korea with experience in 600+ studies
The Only End to End Japan Market Entry Solution Provider

Resources

  • Japan’s PMDA and Malaysia’s NPRA Launch Regulatory Dependency Pilot: Clinical Trial Review Time May Be Cut In Half

    News

Notice regarding Designation as an Orphan Drug and Supplemental New Drug Application for Sodium Phenylbutyrate

  • Notice regarding Designation as an Orphan Drug and Supplemental New Drug Application for Sodium Phenylbutyrate

    News and Events

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Our Tailored Pharmaceutical Solutions

CMIC, Japan’s first and largest Contract Research Organization, offers tailored solutions for pharmaceutical companies, medical device manufacturers, academia, bio-ventures and medical institutions. Using our collective strengths, we offer a broad range of services from preclinical research to practical applications.