• GMP Compliance • 483 Observation, Warning Letter and Consent Decree Response / Remediation
Mark Dockter is a professional solution-focussed CGMP Compliance Consultant with more than 18 years of regulatory and quality assurance success in the pharmaceutical, biopharmaceutical, 503B compounding and cosmetics manufacturing industries. Leveraging substantial experience ensuring compliance with FDA and other regulatory agencies, he is a valuable advisor for any organization seeking assistance remediating an FDA warning letter or consent decree. His broad areas of expertise include compliance, quality assurance, process development and process validation.
Throughout his career, Mark has held leadership positions with MD Pharma Consulting, LLC, Sombra Cosmetics, Albany Molecular Research, Catalent Pharma Solutions and Cardinal Health.