United States

Compliance in Progress

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BioChain is in the process of establishing compliance with more regulation requirements, including GLP, CLIA/HIPPA/PSQIA, and cGMP.

The Good Laboratory Practice (GLP) is the FDA regulation for non-clinical research. CLIA/HIPAA/PSQIA stand for Clinical Laboratory Improvement Amendments/The Health Insurance Portability and Accountability Act of 1996/The Patient Safety and Quality Improvement Act of 2005.

These are the DHHS regulations for clinical diagnostic services. The cGMP stands for current Good Manufacturing Practice, which is the FDA regulation for manufacturing products for clinical usage.