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The comprehensive nonclinical safety testing program required to support clinical development and ultimate registration of a novel therapeutic involves years of work and many different types of studies. This nonclinical safety program - which begins prior to initiation of clinical trials and often continues after a drug is approved for marketing - is an essential component of the pharmaceutical R&D process and represents a considerable financial investment to the innovator.
As CEO/President of Paracelsus, Inc., Grace M. Furman, PhD has been providing professional nonclinical safety services to the pharmaceutical industry as board-certified independent toxicology consultant since 2007.