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.

Moare Solutions offers expertise to assist you in successfully navigating the nonclinical development pathway.

We help to define your nonclinical development plan and design studies to address key nonclinical safety and efficacy endpoints which are necessary but commensurate with regulatory requirements.

We review your existing nonclinical data package for completeness and suitability, and will develop a comprehensive nonclinical plan to address gaps to make the data package more robust and complete and likely to succeed in gaining regulatory agency approval. In addition we can support Scientific Due Diligence exercises to help you minimise risk and make an informed business decision.

We either write the Nonclinical section of your regulatory submission package in the appropriate format, or review the package that you have prepared, ensuring that essential items are thoroughly and appropriately addressed and clearly communicated.

We can attend regulatory agency meetings with you, presenting your nonclinical strategy and addressing agency queries, to facilitate an agreed nonclinical pathway