Clinical development

As per provisions of Directive 2001/83/EC as amended, and Regulation 726/2004/EC as amended, Marketing Authorization Applications in Europe should be supported by results of clinical trials performed according to Directive 2001/20/EC and Regulation 536/2014/EC.

AccepTher also covers the range of scientific expertise necessary for the development and maintenance of "abridged" (i.e. generic, "hybrid"), well established use or fixed-combination products, by helping its clients to solve of the key equation of "how to BE or not to BE?"

AccepTher has a wide experience in designing and managing these studies, and can support its clients throughout all phases of development of “abridged” products, including but not limited to clinical development.