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Offers

Medical Device Program

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 Option

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.

Dedicated team

Post thumbnail Marielle Fournier, Pharm.D.

Marielle Fournier, Pharm.D.

Senior Director, Drugs, Devices & Combination Products

Post thumbnail Christophe Amiel, M.Sc.

Christophe Amiel, M.Sc.

Senior Director, Medical Devices & Digital Life Sciences

Post thumbnail Michaël Auffret, M.Sc.

Michaël Auffret, M.Sc.

Director, Medical Devices & Digital Life Sciences

Neighbors

Orixha
Hemerion
bioadhesive ophtalmics
Gasgon Medical

Meet your new neighbors

We'd love to get to know you

Join us, we offer you an extraordinary chance to learn, to develop and to be part of an exciting experience and team.

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