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Case Studies


Regulatory Compliance through Industry Certifications

BioStorage Technologies maintains a full-time quality assurance staff that is dedicated to developing and following internal protocols and monitoring changing industry regulations. Our clients excel in their highly regulated industries because we follow more than 100 strict standard operating procedures (SOPs).

We maintain the following certifications to ensure your biomaterials are handled, stored and shipped with full regulatory compliance:

  • FDA-registered for GTP (Good Tissue Practices) as they relate to storage and distribution of human cells, tissues and cellular and tissue-based products (HCT/Ps). Registration #3004757032.
  • FDA Title 21 CFR Part 11 compliant
  • New York State Department of Health Licensed Tissue Bank for storage of musculoskeletal tissue
  • IATA (International Air Transport Association) and U.S. DOT (United States Department of Transportation) compliant shipper of radioactive goods and infectious substances
  • NRC (Nuclear Regulatory Commission) certified to store and transport radioactive materials. License #13-32622-01.