Target Product Profile: Definition of the key features of your product to build your industrial development roadmap.
From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.
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.
From EU to US: Suit your innovative therapy to the International regulatory Framework.
Access to Market: Identify the target population & price potential.
Lionel Mavoungou, PhD
Associate Director, Chemistry, Manufacturing and Controls (CMC) & Advanced Therapy Medicinal Product (ATMP)
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