Non-Clinical And Regulatory Expertise Accelerate Development Into Phase II-III Clinical Studies

The client needed assistance with the development of non-clinical program and regulatory documentation to support Phase II-III clinical trials in Europe (daily dosing for one year). The off- patent drug had not been marketed in Europe but was approved and used for more than fifteen years in other regions (and for other indications) at a dosage level five times lower than that in the planned trials.

The client had not conducted any non-clinical pharmacology and toxicology studies. The key challenge was to minimize the number of costly and time-consuming non-clinical studies to be conducted by the client, while still having a high quality non-clinical file to obtain regulatory acceptance by the “top five” European regulatory agencies.