We hold a 351(a) Biological Certification, setting us apart from many other exosome distributors. This certification demonstrates our adherence to the highest regulatory standards for biological products, ensuring that our exosomes meet stringent criteria for safety, purity, and efficacy.

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Mesenchymal Stem Cell (MSC) exosomes, when used for therapeutic purposes, are considered a biological product by regulatory agencies like the U.S. Food and Drug Administration (FDA). This classification requires them to be compliant with section 351(a) of the Public Health Service (PHS) Act, also known as a "351a biological certificate."