Non-clinical Development Advisory

A strong non-clinical development strategy built with the PMDA’s expectations at its core is critical when it comes to efficient drug development in Japan.

IDEC provides a virtual development team ready to support your non-clinical processes, ensuring your product and regulatory strategy are prepared to advance to clinical study. Here’s how we do it.


Non-clinical know-how for Comprehensive, Strategic Guidance

Once you reach the Non-clinical Development Advisory stage of working with IDEC, we’ve already established a development strategy with precise PMDA consultation results. It’s with these regulatory and development plans in hand that we’ll turn to support your non-clinical study programs and ensure you’re on the pathway to approval in Japan.

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Access strategic, big-picture Non-clinical Support

The experts at IDEC will provide non-clinical development advisory that enables your development approach to succeed at the clinical stage. Our services include:

  • Preparation of a non-clinical trial plan outline.
  • Evaluation and selection of non-clinical testing institutions in Japan and overseas—including conducting GLP facility surveys.
  • Professional review of non-clinical study plans.
  • Management of non-clinical study progress.
  • Strategic advice for non-clinical testing institutions.
  • Comprehensive review of non-clinical study reports.

Non-clinical Development Advisory that sets the stage for your clinical study in Japan.

IDEC is here to help.

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