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Certifications, Licenses & Memberships
Compliance is everything. BioStorage Technologies ensures it in multiple ways: over 135 Standard Operating Procedures (SOPs), full-time quality assurance staff, and temperature monitoring four times per second. Plus, we maintain the following certifications to ensure your biomaterials are handled, stored and shipped with full regulatory compliance:
- GTP (Good Tissue Practices)—FDA-registered for GTP as they relate to the storage and distribution of human cells, tissues and cellular and tissue-based products (HCT/Ps) License #3004757032
- FDA Title 21 CFR Part 11 compliant—Intelligent Specimen Inventory Storage System, ISISS®
- Qualtrax® Compliance Software—Document management system for BioStorage Technologies
- Licensed Tissue Bank in these states—New York, California (License #CNC80754), Delaware, Florida (License #145), Illinois (License #0109), Maryland (License #TB1523) and Oregon
- IATA (International Air Transport Association) and U.S. DOT (United States Department of Transportation)—Compliant shipper of radioactive goods and infectious substances
- Nuclear Regulatory Commission (NRC)—Certified to store and transport radioactive materials License #13-32622-01
- Convention of International Trade in Endangered Species (CITES)—Approved for Wild Fauna and Flora import and export of samples with U.S. Fish and Wildlife Permit Permit #LE139625-0
- Animal Health and Monitoring and Surveillance (APHIS)
- Biobanking and Biomolecular Resources Research Infrastructure (BBMRI)— Associated Organisation (AO) as a biobank
- International Society for Biological and Environmental Repositories (ISBER)— Gold Member
