Consulting Services

CMIC Group provides end-to-end solutions for domestic or foreign market entry. Our experts will help you determine the best strategy, in accordance with the country’s regulations and unique environment, working flexibly with your company’s plans for market entry. We provide options for entry at any stage in drug development: before clinical trials have started abroad, after approval abroad or after commercializing in a different country. We also provide partnering opportunities for out-licensing to connect you with other potential pharmaceutical companies and bioventures.

Our Edge in Market Entry and Out-Licensing

Flexible Service Platform

  • We provide flexibility for overseas business partners, providing services that range from clinical trials in the country of entry, to supporting products that were approved abroad.

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.


  • Consultation services for market entry
    • Supports for establishing a company in Japan
    • Optional service for supporting out-licensing activities to Japan
  • Japan Market entry
    • In Country Clinical Caretaker services for clinical trials
    • Marketing Authorization Holder related services (AMAH and MAH)
    • Japanese labeling and mock inspection to prepare for regulatory audits
    • National Health Insurance reimbursement pricing and consultation
  • Asia Market entry
    • Local in-country representative services
  • Laboratory: preclinical data gap analysis
  • Regulatory Affairs support
  • Investigational Product Manufacturing to meet regional labeling regulations
  • Medical affairs organization setup, consultation and resources for Japan
  • Post-marketing surveillance and clinical research
  • Commercial and supply manufacturing meeting regional labeling regulations
  • Sales and marketing planning, setup and resources
in-country clinical caretaker

In-Country Clinical Caretaker (ICCC)

market authorization

Marketing Authorization Holder (MAH)

National Health Insurance

National Health Insurance

IPM Japan

Japan Market Entry/Innovative Pharma Model (IPM)

Orphan Drug

Orphan Drug