A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking points in the product development process. We worked alongside the Client to identify the specific regulatory and scientific gaps in their plan. This critical information helped to form the solid foundation of their regulatory strategy and nonclinical development plan.
Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product
Within a rapidly evolving regulatory scene, medical devices are under high scrutiny. Regulatory requirements are currently being reinforced, in particular to ensure patient safety.