Standards & Assessment For Exosomes/E✓s

The Independent Standard for Exosomes/EVs.

Our purpose: establish the standard for Exosomes/EVs, dissipate the confusion in the field, and accelerate the path to Exosomes/EVs approval in medicine.

Verification. Certification. Trust.

The independent international authority that tests, audits, and verifies what is actually in the vial, so Exosomes/EVs products become verifiable, scalable, and trusted.

SAFE✓™ certifies manufacturing processes. For individual samples, SAFE✓™ provides an independent Certificate of Analysis. Two services. One independent standard.

MISEV2023 Co-Author· 22+ Years Exosome Biogenesis Research· Former EVs Industry R&D Director

How it works: every analytical result submitted by our reference laboratory network is designed to enter a Trusted Execution Environment (TEE), a hardware-secured enclave that even SAFE✓™ personnel cannot access, and then to be cryptographically attested and written to an immutable blockchain. Verification is mathematical, not institutional. You will not need to trust SAFE✓™. You will be able to verify it yourself.

Why SAFE✓™ exists

Nobody is checking what's in the vial.

Billions of dollars flow into Exosomes/EVs therapeutics, regenerative medicine, diagnostics, longevity, and aesthetics. Yet products reach patients with zero independent verification of identity, purity, potency, or biological activity. There is no food-safety equivalent for Exosomes/EVs. SAFE✓™ closes that gap.

Trillions of particles Trillions of exosomes
01 / FAILURE

No independent verification

Manufacturers self-report their own quality data. No outside authority confirms what a product actually contains before it reaches a patient.

02 / FAILURE

No regulatory clarity

Exosomes/EVs products run ahead of the approval pipeline across therapeutics, regenerative medicine, and cosmetics. The rules have not caught up with the field. IRB and IND support →

03 / FAILURE

No reproducibility standard

Batch-to-batch consistency is the unsolved technical problem blocking clinical trials, institutional investment, and industry scale.

What we do

Four Pillars. One Standard.

Four integrated services, all under one roof. Each is stronger because the others exist, and together they form one standard.

PILLAR 01

Consulting & Education

Strategy, SOPs, source selection, lab design, production optimization, and training, from first principles to production.

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PILLAR 02

Testing & Verification

NTA, TEM, Biogenesis Markers, and Purity form the standard verification package, source-agnostic across human, plant, and all origins. Potency, functional testing, and Omics are available at extra charge. Every result is designed to be TEE-attested and blockchain-recorded.

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PILLAR 03

Process Auditing

In-person, on-site GMP and SOP evaluation against international EV characterization standards. Audit data is designed to be processed encrypted, so compliance can be confirmed without any auditor accessing proprietary process data. Your IP is protected by design.

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PILLAR 04

Manufacturing Certification

An in-person audit of the manufacturing process, repeated across the year. The first audit earns the teal seal, certification in process; three audits across the year earn the gold mark, renewed annually and designed to be blockchain-recorded.

How it works →
For Cosmetic Brands

Independent Verification for Cosmetic Exosomes/EVs

No independent body verifies what is actually inside a cosmetic Exosomes/EVs product before it reaches the shelf. Brands self-report; consumers just trust the label. SAFE✓™ closes that gap. We independently verify what is actually inside your product, so you can sell it with confidence and with the science behind it. It is available to any cosmetic brand.

✓

Source-agnostic: human-derived, plant-derived, botanical, every origin, one standard

✓

Cosmetic-grade standards, built by scientists with real formulation experience

✓

Dedicated cosmetic reference laboratory in France, agreement being finalized

✓

A dedicated cosmetic Exosomes/EVs verification, not pharmaceutical rules misapplied

✓

Led by cosmetic EV experts

Scientific Leadership

Led by the Scientists Who Have Done the Work

Dr. Carla Mazzeo

Dr. Carla Mazzeo

Founder & CEO, SAFE✓™

Has personally formulated and compared commercial cosmetic EV products; she knows the quality gap in this category from the inside.

Dr. Raphaël Coatmeur

Dr. Raphaël Coatmeur

SAFE✓™ France

Tests cutaneous penetration, stability, and efficacy on human skin models; the functional proof behind every cosmetic EV claim.

A SAFE✓™ Certificate of Analysis shows your customers that an independent lab has tested a sample of your product, with a result designed so anyone can check it. That is what it means to put the science behind the label.

22+
Years of Exosomes/EVs research & EV industry experience
7
Reference-lab partnerships in progress across six countries
3×
Independent audits in the certification cycle

Verification designed so your customers can check for themselves.

Whether you make Exosomes/EVs products, administer them, or are building toward them, we are here to help you prove your quality and stand behind the science.