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 international regulatory framework.
Access to Market: Identify the target population & price potentia
Digital Medical Device conception (62304 implementation)
Establishing a software under the Medical Device status is a challenge, different standards apply, development under the “agile” form is possible under certain conditions.
IVD (In Vitro Diagnostic) Option
Implementation IVD 98/79/EC
The development of an IVD follows a specific regulation which evolves with the new adjustment.
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