Shellie Dales

Background

About Shellie Dales

bring over 30 years of experience in Quality Assurance, Quality Control, Analytical Development, and Validation across the pharmaceutical, cosmetics, dietary supplement, and regulated product industries. My expertise spans small molecule drug development for semi-solids, liquids, suspensions, tablets, and capsules, with hands-on leadership in regulatory submissions and compliance with FDA/DEA/NSF regulations. I have successfully built and remediated quality systems, led inspections with zero 483 outcomes, validated methods to ICH/USP standards, and implemented programs for elemental impurities, nitrosamine risk, serialization, and DEA-controlled substances (Schedules II–V). My background covers both strategic quality leadership and practical lab, manufacturing, and documentation oversight—always with a focus on inspection readiness, patient safety, and compliance excellence. I am passionate about ensuring that organizations not only meet but exceed regulatory standards, while supporting innovation in product development and commercialization.