Quality Regulatory Compliance LLC is a team comprised of experienced professionals focused and committed to providing quality auditing and consulting services to members of the Pharmaceutical, Medical Device, Bio-Tech, Food, Veterinary, and Importing/Exporting industries. Our goal is to provide our clients with quality consulting and recommendations to ensure compliance with the laws, regulations, policies & procedures enforced by the U.S. Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and other government regulatory authorities
QRC consulting services assist our clients in preparing for FDA inspections (e.g. mock inspections), Pre-Approval, BLA, 510 (K), and PMA inspections. Additional consulting services include providing problem solving and resolution of compliance and enforcement issues, as well as providing assistance to our clients in directing, managing, and responding to FDA correspondence and FDA inspectional observations (FDA 483 cites), and other enforcement actions.