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.
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.
