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Pre-clinical testing

The main goal of pre-clinical studies, before administration of a new drug to humans, is to determine its safety profile. Most pre-clinical studies must adhere to Good Laboratory Practices (GLP) to be acceptable for submission to regulatory agencies such as the Food & Drug Administration (FDA) in the United States or the European Medicines Agency (EMA).

Both organisations have prepared guidelines on the type of data required for new drug applications.

Source BioScience is a fully accredited GLP facility, experienced in supporting regulatory submissions and cross- reactivity studies

In addition to cross-reactivity testing in tissue using FDA and EMA lists, we offer IHC and FISH analysis together with expert pathology review, providing a comprehensive range of tests to meet our clients' needs.

Cross reactivity testing

Source BioScience offers cross reactivity testing to ascertain adverse reactions in a range of tissues comprising FDA and EMA lists. We have a dedicated project team who can help to develop customised study designs to meet project requirements and deadlines.

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