OUR COMMITMENT TO QUALITY STANDARDS
MASTER FILE
YOUR RELAXATION OASIS
At our core, we prioritize safety, transparency, and the highest quality standards in the production of our exosome-based products. Here’s how we ensure the best for our clients:
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FDA Drug Master File
The submission of a Drug Master File reflects our manufacturer’s commitment to regulatory compliance and quality assurance. This ensures that the FDA has all the necessary information to evaluate the safety, potency, and manufacturing processes of our products. -
Third-Party Testing
Every batch of exosomes we offer undergoes rigorous third-party virology testing to ensure their safety and quality. This independent testing verifies that the exosomes are free from viral contamination, providing transparency and confidence in the product's development and use. -
cGMP Compliance
All of our exosome products are manufactured in ISO-5 cleanrooms at facilities that adhere to Current Good Manufacturing Practices (cGMP), ensuring top-tier production standards and product consistency.
351 (a) BIOLOGICAL CERTIFICATION
WHAT SETS US APART
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.
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."
