Quality and Regulatory Compliance

Quality and Regulatory Compliance

Humabiologics, LLC strives to meet customers research needs by providing biomaterials that comply with requirements for transplantable human tissues under 21 CFR 1271. This is done by working with FDA registered tissue processing facilities and regional Organ Procurement Organizations to obtain source materials that meet all applicable industry regulations.


While Humabiologics biomaterials are not intended for transplant unless used as part of FDA submission including  IND, 510(k), or PMA, Humabiologics is registered as a Human Cellular and Tissue Processing Establishment with the Center for Biologics Evaluation and Research (CBER) division of the FDA and maintains quality systems that comply with 21 CFR 1271.


Please contact us with any specific questions or additional information on how Humabiologics might be able to assist your organization with their specific research needs including providing materials that comply with cGMP for clinical trials or research.