CMC Advisory

IDEC offers expert CMC advisory and support for pharmaceutical product development efforts in Japan, ensuring efficient, reliable compliance.

Our experienced virtual development team will devise and support your CMC pharmaceutical strategy for products of all complexities and specifications. Here’s how we do it.


Full life-cycle support for CMC Regulatory Compliance

CMC regulatory compliance requires pharmaceutical innovators in Japan to ensure they follow agreed upon practices in the development phases of their product. IDEC has the in-house expertise to ensure CMC compliance for your product—whether small molecule, large molecule, biopharmaceutical, or regenerative therapy—all the way from pre-clinical development to post-market lifecycle management.

Cmc Regulatory Compliance
Cmc Regulatory Expertise

Access Japanese CMC Regulatory Expertise

CMC regulatory compliance demands region-specific, experienced support, and IDEC is proud to offer regulatory advisory built to ensure your development’s adherence. Our services include:

  • General CMC regulatory compliance education.
  • CMC due diligence management.
  • ICH guideline proposal development and support.
  • PMDA quality compliance management.
  • IMPD / IND clinical trial material review.
  • ICH-M7 summary preparation.

Engage comprehensive Application Preparation and Submission Services

When it comes time to prepare and submit approval applications to the PMDA, IDEC stands ready to strategize and implement your process. Our services include:

  • Application strategy development and proposal.
  • CTD (M2.3, M3) evaluation, advice, preparation, and revision—including gap analysis.
  • Approval application preparation.
  • MF registration application preparation.
  • JAN registration / notification material preparation.
  • Foreign manufacturer certification support.
  • GMP inspection response.
  • Import drug investigative support.
Cmc Application Preparation Submission

Receive complete, expert-led, full-lifecycle CMC regulatory compliance advisory support in Japan.

IDEC is here to help.

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Application Preparation & Submission

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KOL Management

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Market Entry Planning

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