The generation of a robust nonclinical data package is critical to thoroughly evaluate the safety and efficacy of innovative therapies, such as cell and gene therapies and vaccines, to enable regulatory success. These novel medicines typically do not follow traditional development pathways but require a bespoke case-by-case approach based on a deep understanding of the science and a thorough assessment of the potential safety considerations. We can expertly assist you in successfully navigating the nonclinical development pathway. We provide the following nonclinical services: - Nonclinical Strategy and De Novo Design - Gap Analysis and Due Diligence - Nonclinical Dossiers - Regulatory Agency Meetings