Development Strategy Planning
At IDEC, your journey down the regulatory pathway to approval in the Japanese market begins with our approach to Development Strategy Planning.
Our services include an initial development evaluation that will inform our innovative development strategy planning process. Here’s how we do it.
We start with an Initial Development Evaluation
Before we begin formalizing our development strategy for your product, we conduct a thorough initial development evaluation that explores non-clinical, clinical, and CMC product details. We work to evaluate the sufficiency of your trials and the potential development risks based on Japan’s unique regulatory requirements and guidance. If risks or gaps are identified, we’ll work with you to design and deploy strategies for their mitigation.
During this process, we pay careful consideration to analyze any gaps in overseas data. We also create potential development scenarios for Japan and consider their overall strengths and weaknesses, ensuring the stage is set for a formal development strategy for the market.
That evaluation supports our innovative approach to Development Strategy Planning
With our initial development evaluation in hand, we’re able to create a development strategy for your product with our sights set on a short, efficient approval pathway. Our Development Strategy Planning services will drive efficiency into your approval process by performing the following:
- Considering environmental factors such as guidelines, regulatory trends, competitive development status, and overall marketability
- Minimizing future development risk through early identification and planned mitigation
- Formulating a strategy inclusive of the optimized approval application data package according to disease area and product characteristics—whether regenerative medicine, orphan drug, competitive situation, or more
- Prosing a development strategy that accounts for the right Japanese pharmaceutical market entry strategy
Ultimately, IDEC’s Initial Development Evaluation and Development Strategy Planning will yield a worthwhile reduction in both time spent and overall cost.
Are you ready to begin?
