Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

Quality

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)

 

Certifications

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.

Copyright 2015 NANOTHERAPEUTICS, INC.  All rights reserved.