Regulatory Affairs and Quality

MC3 has dedicated personnel working in Regulatory Affairs and Quality Assurance as part of the ORAQ Team. The Regulatory team manages FDA regulatory submissions, handles meeting requests with the FDA and provides overall regulatory strategy. The Quality Assurance team provides dedicated support to Good Manufacturing Practice (GMP) facilities and products, including the Robertson GMP Laboratory and the Carolinas Cord Blood Bank (CCBB). The Quality Assurance team is responsible for the review of batch records and other quality documents, events management, release of supplies, quality agreements, vendor qualification and internal and external audits. The Quality Assurance team is supported by document specialist staff.