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For customers outside of Japan

CMC Regulatory Services

In the field of CMC, our expert staff apply highly specialized skills to perform the tasks described below. They deliver regulatory affairs services of impeccable quality in support of customers inside and outside Japan across a broad range of activities.
Our CMC services range from support for drug substance filings and drug product approvals, to advice on GMP and consistency check.

Services Outline

Accreditation of Foreign Manufacturers

  • New Accreditation
  • Renewal of Accreditation
  • Addition of Accreditation Category


Regulatory CMC consultation

  • Support of Marketing Authorization Application

- Preparation of Application Form

- Support preparation of attached documents

Performance Profile

We will tailor an ideal solution for your specific needs.

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