Company Description

TLC Regulatory and Laboratory Consulting (TLC) provides Food and Drug Administration (FDA) regulatory consulting services and scientific expertise to the dietary supplement, pharmaceutical, tobacco, and cannabis industries. This includes assisting clients throughout the world with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical, and compliant with all applicable FDA regulations. Performing mock FDA inspections, gap analyses, due diligence assessments, and audits directly for clients as well as audits of contracting partners including manufacturers, packagers, distribution warehouses, and laboratories. TLC also works with clients on regulatory remediation efforts and necessary corrective and preventative actions. In addition, TLC conducts thorough and detailed quality incident investigations including out of specification (OOS) investigations, non-conformances, material reviews, deviations, general quality investigations, and consumer complaints. Training services include seminars, webinars and on-site presentations on topics of Current Good Manufacturing Practice (cGMP) requirements, quality systems, and laboratory operations.