Parexel Consulting has expanded its risk management and strategic compliance expertise with the appointment of Anthony C. Warchut, formerly an investigator in the FDA Pharmaceutical Inspectorate. Mr. Warchut brings 29 years of FDA pharmaceutical inspection experience to the company, and joins a global network of consultants dedicated to addressing the full range of risk management challenges facing companies.
Mr. Warchut has extensive experience with complex products, technologies and advanced pharmaceutical manufacturing processes. The Pharmaceutical Inspectorate was established as a result of the FDA's "Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach," a major global initiative to ensure the quality of drug products. His experience also includes inspections of sponsor/monitors, clinical investigators, bioequivalence laboratories and non-clinical laboratories, as well as inspections involving the FDA's Application Integrity Policy.
"Tony is the first of the Pharmaceutical Inspectorate cadre to leave the FDA and join industry and we are proud that he selected PAREXEL Consulting," said Gadi Saarony, general manager of the Strategic Compliance and Operational Excellence Practice at PAREXEL Consulting. "Tony brings the deep expertise our clients need to help assure product quality and safety and to proactively identify and manage risks associated with biopharmaceutical product and medical device development."