Target Product Profile: Definition of the key features of your product to build your industrial development roadmap.
Regulatory Landscape: Build the interaction plan and strategy of communication with EMA & FDA.
Nonclinical Development: Choose the right model for your evidence based strategy.
Clinical Plan: The backbone of your entire development plan.
CMC Accelerated Development: Help in achieving a scale up of your production method.
Access to Market: Identify the target population & price potential.
Small Molecules Option
Strategic help on: sub-contract interactions and technical challenges.
New innovative processes exist to develop and bring small molecules into the market, such as setting up Clinical Trials “in silico”, evolving validation strategies for accelerated production method.
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