Nonclinical Development

Voisin Consulting Life Sciences offers nonclinical regulatory support to help our clients build a strong nonclinical development, including the rationale, the strategy, and the implementation of this plan. In particular, we assist with the extrapolation of animal data to humans, in order to design the First-in-Human study, as well as subsequent clinical trials.

Based on Emmanuelle Voisin’s expertise, as former reviewing Pharmacologist and Toxicologist with the US FDA CDER Division of Antiviral Drug Products, and on the strong nonclinical technical background and regulatory expertise of our nonclinical experts, we are well prepared to anticipate hurdles and help coordinate nonclinical activities in line with the development phases of our clients’ programs. We also prepare the corresponding non clinical regulatory submissions, such as Modules 2.4 and 2.6, as well as Module 4 for CTD submissions to the EMA, European regulatory agencies, and US FDA.