Cheri A. Wilczek, M.S.
Founder and President, ClinAudits LLC
Cheri A. Wilczek, M.S., B.S., 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), Good Distribution Practice (GDP), REMS and Good Tissue Practice (GTP) auditing services and has managed its growth since the company’s inception in 1994. She has over 35 years in the regulated pharmaceutical industry. ClinAudits assists clients in the pharmaceutical, biotechnology, biologic, gene therapy, tissue engineering, medical device industries, OTC, RX, and medical universities and institutions and is focused on meeting end-to-end FDA and other governmental authority GxP compliance requirements around the world.
The company operates strictly within the regulations/guidelines set forth by the FDA and other worldwide governmental authorities, regulations/guidelines designed to bring products to market which have demonstrated adherence to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety. Because we do not conduct or manage clinical trials, ClinAudits is well positioned to emphasize our 100% objectivity and independence across a comprehensive portfolio of critical services.
ClinAudits is proud to have attained a Women-Owned Business Enterprise Certification.
Cheri obtained 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 prior positions with The Upjohn Company and Hoffmann La Roche.
Chief Financial Officer, ClinAudits LLC
Jim has been with ClinAudits for 14 years and has served in various capacities within the pharmaceutical industry for more 28 years. His principal experience has been in the animal health industry which included global product development, drug discovery research, and technology assessment. Jim earned his M.S. and Ph. D. degrees at Cornell University and a B. S. degree at the University of Connecticut.