Creative Solutions to Support Your Japan Market Entry

CMIC is the true end-to-end solution partner in Japan with leading industry experiences and solid track record. CMIC provides full pharmaceutical capabilities for overseas business partners to enter into Japan market. If you wish to conduct a clinical study in Japan, we can serve as the required In-Country Clinical Caretaker (ICCC). If you want to commercialize a new product, we can act as the Marketing Authorization Holder (MAH) or connect you with a strategic licensing partner. Our experienced consultants can help you determine the best strategy in accordance with Japan-specific changing regulations and unique environment, with options for entry at any stage in drug development: before clinical trials have started abroad, after approval abroad or after commercialization in a different country.

Our Edge in Japan Market Entry

As Japan’s first and largest CRO, we are the most experienced partner in Japan for drug development

  • 30+ years of industry experience with end-to-end solutions from preclinical to clinical development, from formulation to manufacturing, from filling to sales & marketing
  • CMIC can serve as an In-Country Clinical Caretaker (ICCC) for oversea sponsors

Strong expertise from strategy planning to commercialization

  • As Japan’s largest Consulting Service partner, we can help you to create the best strategy in accordance with Japan-specific changing regulations and unique environment and fit your business needs
  • We provide all services necessary for maintaining the manufacturing and sales of products in Japan, including commercial manufacturing, marketing, sales/distribution, and medical affairs, pharmacovigilance, PMS, quality assurance and regulatory affairs activities.

Japan Market Entry Solutions

Tailoring our services to meet your Japanese market entry needs

IPM chart

For the unique and flexible Japanese Market Entry support provided by OrphanPacific, please click here for more information.


In-Country Clinical Caretaker (ICCC)

market authorization

Marketing Authorization Holder (MAH)

Post-marketing surveillance-RGB

Post-Marketing Surveillance



Commercial Supply

Commercial Supply

Drug Manufacturing

Contract Development & Manufacturing

medical device

Medical Affairs


Regulatory Affairs

Consulting Services

Consulting Services


Orphan Drug

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