Four Pillars. One Standard.
Four integrated services, all under one roof, from first strategy to a cryptographically verifiable mark. Each is stronger because the others exist, and together they form one standard.
Consulting & Education
Strategy and know-how, from first principles to production.
- Strategic advisory
- SOP development
- Source selection guidance
- Lab infrastructure design
- Production optimization
- Education workshops & clinical training
Testing & Verification
The standard verification package, designed to be TEE-attested and blockchain-recorded.
- NTA, particle count & size
- TEM & electron microscopy
- Biogenesis markers, identity & origin
- Purity analysis
- Potency & functional testing (extra)
- Omics (extra)
Process Auditing
MISEV2023 compliance, evaluated without exposing your IP.
- Manufacturing site evaluations
- MISEV2023 compliance analysis
- Workflow optimization
- Actionable remediation plans
- Negative characterization support
- Designed as an encrypted, AI-secured process audit
Manufacturing Certification
The SAFE✓™ mark: the process is certified, the product is verified.
- Product verified: identity, purity, potency, bioactivity
- Process certified: GMP, SOP, in-person audit
- Designed to be blockchain-recorded and cryptographically verifiable
- Teal seal after the first audit, gold mark after three audits across the year
- Public registry of certified companies
- Annual renewal
One standard. Five audiences.
Whether you make Exosomes/EVs products, administer them, or are building toward them, SAFE✓™ gives you verified ground to stand on.
EV & Exosome Manufacturers
Replace self-reported data with independent proof.
Companies producing Exosomes/EVs products for therapeutics, diagnostics, regenerative medicine, and aesthetics.
- SOP development & production optimization
- Formulation, excipient selection & packaging
- Testing: NTA, TEM, bioactivity, safety & purity
- Auditing: MISEV2023 compliance gap analysis
- Certification: a cryptographically verifiable mark
Clinicians & Physicians
Know what you administer, before you administer it.
Practitioners giving EV products to patients who need verified product quality first.
- Independent product testing before administration
- Formulation & storage guidance to preserve bioactivity
- Indication-specific clinical application protocols
- Certification as the fastest supplier-quality signal
- Comparison testing, know what is in any vial
Building from Zero
From concept to certified manufacturer.
Entrepreneurs and scientists building an EV production company from the ground up.
- Strategic foundation: target application & regulatory pathway
- Cell-source selection and lab design from day one
- Production-method development and SOP creation
- Quality-system design and a path to certification
- Guidance at every step of the build
Academic Researchers
Characterization without the capital outlay.
Universities studying Exosomes/EVs that lack capital for characterization equipment.
- Testing services on submitted samples, no equipment to buy
- MISEV-compliant characterization reporting
- Education workshops and training programs
- Collaboration on standard-setting research
Trial & Regulatory-Track Companies
Evidence for ethics committee review and the path to trial approval.
Companies developing native or engineered exosome therapies toward ethics committee review and clinical trial application.
- Ethics committee review preparation: trial-ready documentation
- Characterization support for regulatory-ready packages
- Independent verification of identity, purity & potency
- MISEV2023-based criteria, not self-certified claims
- Results designed to be tamper-evident and blockchain-verified
Find the right pillar.
Tell us what you're building or administering and we'll point you to the right service.