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Non-Clinical Expertise

Although pre-clinical activities are required in the overall clinical programme as part of the safety assessment there may even be a need to conduct pre-clinical additional studies post-marketing as well.

The pre-clinical expert is vital in interpreting the data that will be written as part of the submission document together with the individual studies completed and any possible safety findings seen in the animal studies which may potentially have an effect in humans too.

PharSafer® works with leading toxicologists and pre-clinical safety experts and pre-clinical specialist CROs working with animals and in vitro situations in order to help clients complete their pre-clinical package for submission for a licence or as a specialist post-marketing study.

PharSafer® Tweets

The @FDA_Global has updated their summative COVID-19 response document, with amendments made for latest activities… t.co/j9oudR40O0

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