Proof of what is in the vial.
A Certificate of Analysis is an independent test of a single sample. Our reference laboratory network will characterize identity, purity, and potency, and the result will be issued as a Certificate of Analysis bearing the SAFE✓™ logo. A Certificate of Analysis tests one sample. It does not certify a manufacturer’s process, and it does not earn the teal seal or gold mark, those are reserved for labs in our Certification program.
Independent lab testing, not self-reporting.
Manufacturers self-report their own quality data. Verification replaces that with an independent measurement of what is actually inside the product, with a record designed so anyone can confirm it without contacting SAFE✓™.
- Identity, purity & potency measured
- Source-agnostic: human, plant, botanical, every origin
- Designed for attestation inside a Trusted Execution Environment
- Designed to be blockchain-recorded & independently verifiable
- Issued as a Certificate of Analysis carrying the SAFE✓™ logo
SAFE✓™ Certificate of Analysis
Verify it yourself.
Every verification is designed to be independently checked by anyone, anywhere, without contacting SAFE✓™. The mathematics proves it.
What we test.
Standard package
NTA, TEM, Biogenesis Markers, and Purity. Source-agnostic across human, plant, and all origins. Every result is designed to be attested and blockchain-recorded.
Available at extra charge
Potency, functional testing, and Omics, for teams that need deeper functional proof of what the product does.
Verified near you
Samples will be tested at a reference laboratory close to your production site, quickly and under the regulations that apply where you operate.
From sample to Certificate of Analysis.
Submit
You will submit product samples through a confidential intake to a reference laboratory near your site.
Characterize
The lab will run the standard package: NTA, TEM, Biogenesis Markers, and Purity. Potency and Omics are available at extra charge.
Attestation
The result is designed to be processed inside a Trusted Execution Environment, cryptographically attested, and written to the blockchain, so that no human touches it.
Certificate of Analysis issued
The product will earn a Certificate of Analysis bearing the SAFE✓™ logo.
What it actually takes to call your vesicles exosomes.
Size
NTA: NanoSight · ZetaView
Nanoparticle Tracking Analysis (NTA) measures particle size distribution. Essential starting point, not the conclusion.
- Size distribution
- Cannot distinguish vesicle from particles, aggregate or lipoprotein
Structural evidence
TEM · Cryo-EM
Confirm membrane-enclosed vesicles: morphology via TEM or Cryo-EM.
- Confirms particles are membrane vesicles
- Cannot confirm where those vesicles came from
Identity
Proteomics · ImmunoGold
Exosome-specific biogenesis markers confirmed.
- Exosome markers in the sample
- Exosome markers alone do not confirm those markers sit on an intact membrane, you need to confirm that with size and morphology.
Endocytic origin: MVB biogenesis
To call vesicles exosomes, you must demonstrate they were produced inside the Multivesicular Body (MVB) via the Ceramide pathway, ESCRT-independent, and secreted upon MVB-plasma membrane fusion.
Without this, you have vesicles, but not exosomes (exosomes are the functional subset of Extracellular Vesicles).
Functional potency assay
None of the above confirms your preparation works. Efficacy requires a cell-based functional and potency assay, relevant to the therapeutic claim, reproducible and validated.
More ≠ better. Acceptor cells need a specific threshold. Supraphysiological counts do not increase efficacy.
De-risking the path to global trials.
Exosomes are redefining the future of medicine, but whether you are developing native or engineered exosome therapies, the path to a clinical trial application (IND, CTA, and equivalent submissions) is where scientific promise meets regulatory scrutiny. Ethics committee review and that application both require evidence a sponsor cannot self-certify.
SAFE✓™ prepares that evidence base: trial-ready documentation for ethics committee review, characterization support for regulatory-ready submissions worldwide, and independent verification of vesicle identity, purity, and functional potency against MISEV2023 criteria, with data designed to be tamper-evident and blockchain-verified, not a claim on a slide.
- Ethics committee review preparation: trial-ready documentation for your submission
- Characterization support for regulatory-ready packages, from FDA to EMA, MHRA, and beyond
- Independent verification of identity, purity, and functional potency against MISEV2023 criteria
- Results designed to be tamper-evident, blockchain-verified, and checkable by anyone
Ready to prove what is in your vial?
Start with an independent Certificate of Analysis for your sample. To certify your manufacturing process, see Certification →