Quality & Compliance
Quality & Compliance
Human tissue handled with the stewardship the gift of donation deserves.
Regulatory posture
Held to stringent standards
The allografts we distribute are human cells, tissues, and cellular and tissue-based products (HCT/Ps) handled under the requirements of 21 CFR Part 1271. Product claims are limited to minimal-manipulation, homologous use.
Draft — specific FDA registration and any AATB accreditation language will be confirmed with the client before publishing.
Our commitments
- Partnered with tissue banks that perform rigorous donor screening and eligibility determination
- Full traceability from recovery through distribution
- Validated processing at the source, including the PASCO2® supercritical CO₂ method
- Controlled storage and handling that preserves tissue for its intended function through final distribution
- Respect for donors and their families at every step
Responsible donation
Where the standards begin
- Comprehensive medical and social evaluation of every donor
- Clinical history review
- Documented physical examination
- Serological and microbiological testing
Analyses are conducted in certified laboratories under CDC and CLIA standards, complying with federal regulations and international ethical guidelines.