The first step is to identify the target indication based on the assumed mechanism of action of your product and then select the appropriate preclinical disease models. B4D will ascertain which disease models are favoured by both clinical experts and regulatory authorities and work with academic experts or CROs to conduct these experiments in validated models. B4D will assist in the design of the protocols ensuring that each study is maximized to provide information on effects on biomarkers, clinical indicators, safety, pharmacokinetics and dosing. While there is not a requirement for conduct under GLP at this stage, B4D will assure GLP-like conduct of these studies and the issuance of IND quality final reports.