Compliance in Progress

BioChain is in the process of establishing compliance with more regulation requirements, including GLP, ISO 13485, CLIA/HIPPA/PSQIA, and cGMP.

The Good Laboratory Practice (GLP) is the FDA regulation for non-clinical research. ISO 13485 is the ISO standard for manufacturing in vitro medical devices. 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.