Nanotherapeutics has an established Quality Management System (QMS) that is compliant with:
- 21 CFR 210 and 211 (Drugs)
- 21 CFR 600, 606 and 610 (Biologics)
- 21 CFR 820 (Medical Devices)
- 21 CFR 1270 and 1271 (Human Cells, Tissues and Cellular and Tissue-Based Products)
- ISO 9001 (General Quality Systems)
- ISO 13485 (Medical Devices)
Nanotherapeutics is registered as a manufacturer of human tissue products with the FDA (FDA License 07-1365). Nanotherapeutics facility has been inspected by the Florida Department of Health (FDOH) and audited by the FDA (2010 and 2012). Nanotherapeutics QMS is compliant with 21 CFR 210/211 (GMP of Pharmaceutics), 820 (Quality System Regulation). Nanotherapeutics QMS also received ISO 9001 and 13485 certification in 2012.