Non-clinical Overview/Summary (Modules 2.4/2.6)
Nonclinical Overview and Summary are a part of common technical document and contain the interpretation and a synopsis of the results from animal studies with the investigational product. The main purpose of these Nonclinical modules is to describe the safety profile of investigational medicinal product to regulatory authorities.
Here in Biomapas, scientific expertise drives the competent interpretation of the nonclinical data and enables us to draw relevant safety conclusions pertinent to human use and safety, whereas regulatory expertise drives the contents, format and compliance of these documents. Our medical writers can prepare harmonized Nonclinical modules for you and update or perform a gap analysis of your own Nonclinical Overview and Summary as well.