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Cell & Gene Therapy 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 the International regulatory Framework.

Access to Market: Identify the target population & price potential.

Dedicated Team

Post thumbnail Emmanuelle Sabbah-Petrover, PhD

Emmanuelle Sabbah-Petrover, PhD

Director, Complex Biologics

François Gianelli thumbnail

François Gianelli

Associate Director, CMC & Quality

Post thumbnail Decebal Bora, Pharm.D., MPH

Decebal Bora, Pharm.D., MPH

Vice President Regulatory Strategy

Post thumbnail Cécile F. Rousseau, PhD

Cécile F. Rousseau, PhD

Director, Nonclinical

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