Cheri Wilczek, MS, BS
Cheri A. Wilczek is the founder and President of ClinAudits, LLC, a recognized leader and independent, niche provider of domestic and international Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Tissue Practice (GTP) auditing services, and has managed its growth since the company’s inception in 1994. She has more than 32 years in the regulated pharmaceutical industry. ClinAudits assists clients in the pharmaceutical, biotechnology, tissue engineering, medical device industries, OTC, RX, gene therapy, and medical universities and institutions, and is focused on meeting end-to-end FDA and other governmental authority compliance requirements around the world.
The company operates strictly within the regulations/guidelines set forth by the FDA and other governmental authorities; and regulations/guidelines designed to bring products to market that have demonstrated adherence to exacting standards in terms of manufacturing and production, field-proven efficacy, and patient safety. Because they do not conduct or manage clinical trials (eg, IVRS and EDC processes), ClinAudits is well positioned to emphasize their 100% objectivity and independence across a comprehensive portfolio of critical services.
ClinAudits is proud to have attained a Women-Owned Business Enterprise Certification.
Cheri received her bachelor of science degree from the University of Delaware, and her master of science degree in genetics from the University of Maryland.
Prior to founding ClinAudits, Cheri had positions with The Upjohn Company and Hoffmann La Roche.