Chris Ernst
About Chris Ernst
Chris Ernst – VP of CMC
Chris Ernst is the Vice President of Chemistry, Manufacturing, and Controls (CMC). With a deep expertise spanning over 25 years, he has accrued significant experience in various industry settings. His role as VP of CMC involves overseeing the chemical, manufacturing, and control aspects of pharmaceutical products, ensuring they meet rigorous standards and compliance requirements.
Chris Ernst's Industry Experience
Chris Ernst has more than 25 years of comprehensive experience in the healthcare and pharmaceutical industry. His career includes 18 years focused on research supporting nonclinical and clinical phases for investigational drug applications, biologics, and pivotal bioequivalent investigational products. His extensive background has given him a robust understanding of the industry’s regulatory landscape and manufacturing practices.
Regulatory Compliance and Auditing
Chris Ernst has a strong background in ensuring regulatory compliance across a spectrum of practices including Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). He has led audit teams of regulatory inspectors from various international regulatory bodies, including the FDA, Health Canada, and numerous EU countries. His expertise extends to compliance with global regulations including OECD guidelines and medical device oversight.
Consultation and Regulatory Approval
Chris Ernst serves as an expert consultant in the pharmaceutical industry, particularly in establishing the acceptance and approval of Investigational New Drug (IND) applications and achieving New Drug Application (NDA) approvals. His consultancy has been pivotal in securing regulatory approvals from major authorities such as the US FDA and the European Medicines Agency (EMA).
Manufacturing Practices and Clinical Trials Support
Chris Ernst has supported manufacturing practices across the pharmaceutical spectrum, from drug substances like small molecules and proteins to drug products including solid oral doses and sterile injectables. His support extends to various formulations such as capsules, topical ointments, and ocular drops. Additionally, he has facilitated the advancement of drugs delivered orally, subcutaneously, dermally, intravenously, and topically through Phase 1 to Phase 3 clinical trials.