Application Preparation & Submission

Before IND Applications can be submitted to the PMDA in Japan, the governing body requires them in a special Common Technical Document (CTD) format.

IDEC offers complete CTD preparation and submission support grounded in experience and local regulatory know-how. Here’s how we do it.

Pragmatic, complete CTD Preparation & Submission

Building an application in the appropriate Japan CTD format means understanding the information the PMDA needs to review and the board’s preferences for efficient submission approval. At IDEC, we provide complete application preparation and submission support that is as thorough as it is compelling and complete.

  • We create easy-to-read, quality documents built with contemporary regulatory concerns in mind, thus minimizing the number of inquiries in approval review.
  • Leave the heavy lifting to us as our initial assessment and strategy development are enough to guide us to prepare a quality CTD.
  • Our experience means we can support applications for products with limited clinical, non-clinical, and CMC data—due, potentially, to rare disease or technical shortcomings.
  • When it comes to working with overseas pharmaceutical companies, we provide extensive experience in international collaboration for gap analysis, consensus building, meeting attendance, and material preparation.

All CTD preparation work is done in a modern cloud environment. IDEC offers an integrated, cloud-based approach to document creation, review, finalization, eCTD conversion, and, finally, printing and binding.

Ctc Preparation Submission
Post Application Support

Access unwavering Support after Application Submission

Our work doesn’t stop at Japan CTD submission to the PMDA, either. We’re committed to working directly with the PMDA for inquiry response, negotiation, GMP survey, inspection, and more through the complete application lifecycle.

Access comprehensive application development & submission services and the complete support system you need for efficient entry into Japan.

IDEC is here to begin.

Learn more about how IDEC can serve you.

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Are you ready to streamline your entry into Japan with IDEC?