Avazyme has a proud history of analyzing materials, developing methods, and producing verified data for United States and international government regulatory agencies as well as some of the country’s most well-trusted, private sector biotech companies.

Along with being permitted to accept and handle DEA schedules I-V materials, we routinely accept photosensitive, moisture sensitive, and oxidation sensitive materials. We are not licensed to receive or handle radioactive materials. Listed here are some of our certifications:

  • ISO17025:2017 accreditation
  • Good Laboratory Practice (GLP)
    • EPA (40CFR160)
      • EPA Audit 2020
  • FDA (21CFR58)
  • FDA (21CFR11)
  • Good Manufacturing Practice (support)
    • FDA Registered Laboratory Facility
    • 21CFR210/211 (Pharmaceuticals)
    • 21CFR100 (Food)
    • 21CFR500 (Feed)
    • 21CFR1100 (Vape Products, Cigarettes)
  • Controlled Substance Permits
    • DEA (All Schedules)
    • NC DHHS (All Schedules)
  • Controlled Organisms under USDA-APHIS Permits
    • All bacteria (blanket permit) at BSL-2 or less.
    • Certain other microbes (list available upon request)