Chris Ernst

Chris Ernst is a research scientist with over 25 years’ experience in a variety of industry settings. Chris’ experience includes 18 years of research experience in support of nonclinical and clinical research in support of investigational new drug applications, amended new drug applications, combination products, biologics, and pivotal bioequivalent investigational products. During this time, he has have ensured regulatory compliance in support of Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP), College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Organization for Economic Cooperative Development (OECD), and Medical Device oversight including US FDA and associated international global regulations (ICH, EU Directives, etc.). Additionally, he has lead audit teams of regulatory inspectors from multiple international regulatory bodies including US FDA, Health Canada, Chile and other Latin and South American regulatory authorities, multiple member countries within the European Union (EMA), China, South Africa, Australia, India, and Russia. Chris has also served as an expert consultant to establish acceptance and approval of IND applications to achieve approval NDA by the US FDA, EMA, and other international regulatory authorities. His experience includes support of manufacturing practices from drug substance manufacturing and intermediate/registered starting materials manufacture including small molecule, proteins, and monoclonal antibodies from humanize mammalian strains, to drug product manufacture including solid oral dose, capsule, topical ointments, sterile injectables, and sterile topical ocular drops. This work has supported advancement of oral, subcutaneous, dermal, intravenous, and topical ocular-delivered drugs to Phase 1 through Phase 3 clinical trials.