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Start With a Supplier
You Can Verify

Everything you need — compliant products, full documentation, and a partner lab you can verify.

Lab scientist in controlled environment
FDA Registered & Inspected Facility

Not Every Supplier Can Protect Your Practice

The regenerative biologics space is growing fast — and so are the risks. Misrepresented products, non-compliant sourcing, and suppliers who can't provide basic documentation put your practice and your patients at risk.

If your supplier can't show you full transparency of their lab, their manufacturing process, their certifications, and their chain of custody — you're operating with unnecessary exposure.

“You can't just trust your supplier. You have to question them to ensure your practice isn't at risk.”

Feel Confident. Feel Secure.

Compliant products, full documentation, and a partner lab you can verify.
This is the standard — demand it from any supplier.

FDA Registered & Inspected
Our partner lab is an FDA-registered outsourcing facility, licensed to ship biologics nationwide. Registered and inspected — not just registered. Inspection records available (Forms 482 & 483). Can your supplier provide theirs?
cGMP Compliant
Aligned with 21 CFR Parts 210 & 211 Good Manufacturing Practice. Every stage of production follows defined controls for consistency and safety.
COA with Every Shipment
A Certificate of Analysis accompanies every product shipment — independent third-party verification of viability, sterility, and quality.
Active FDA IND
Products backed by an active Investigational New Drug application with the FDA. Includes IND status and ClinicalTrials.gov registration — the highest standard of clinical accountability.
Chief Science Officer Oversight
Named PhD scientist and MD oversight across product development, quality assurance, and regulatory compliance at every level.
IRB Documentation
Institutional Review Board documentation ensures ethical sourcing and donor consent protocols. IND status and ClinicalTrials.gov number available for full clinical traceability.
NanoSight Data Reports
Post-thaw NanoSight data reports available confirming particle count and size distribution claims. Transparent, verifiable data — not just a number on a label.
ISO Certified Cleanrooms
ISO Class 5 (Aseptic Operations), ISO Class 7 (Processing & Testing), and ISO Class 8 (Preparation & Support). Maintained through HEPA filtration, continuous environmental monitoring, and data-driven QA.
Full Lab Transparency
Complete visibility into the lab, manufacturing process, certifications, and handling. If we can't show it, we don't sell it.

“You've worked hard to build a practice with a reputation. Let Sōlix give you the confidence to integrate regenerative human biologics without fear.”

Cryogenic vial preparation
Cryogenic vial preparation under ISO 5 cleanroom conditions

Your Practice. Protected.

You've built your reputation. Don't risk it on a supplier who can't show you everything.

Built by AUSTAN

DISCLAIMER

Sōlix does not own, operate, or manage any laboratory, manufacturing, or compounding facility. All biological products available through this platform are manufactured, processed, and distributed by our independently owned and operated FDA-registered laboratory partners. Sōlix does not distribute, ship, handle, or take possession of any biological product at any point in the supply chain.

Sōlix operates as a provider platform that offers licensed healthcare practitioners access to product ordering, clinical education, implementation support, marketing resources, and business integration tools designed to help practices incorporate regenerative biologics into their clinical offerings.

Sōlix is not a compounding pharmacy or chemical compounding facility as defined under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Sōlix does not compound, manufacture, repackage, or relabel any drug or biological product.

Sōlix resources are for educational and informational purposes only. Providers are responsible for their own regulatory compliance, licensing, and insurance. Sōlix assumes no liability for how materials are applied in practice.

FDA DISCLAIMER

The statements made on this website have not been evaluated by the U.S. Food and Drug Administration. The products and services referenced on this platform are not intended to diagnose, treat, cure, or prevent any disease or medical condition. Biological products, including but not limited to stem cells, exosomes, Wharton's Jelly, and amniotic tissue allografts, are minimally manipulated human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under 21 CFR Part 1271. These products are intended for homologous use only and are administered at the sole discretion of a licensed healthcare provider following individual patient assessment. Results may vary. No guarantees of specific outcomes are made or implied.

All medical decisions, including the use of regenerative biologics, should be made in consultation with a qualified healthcare professional. Sōlix makes no medical claims and assumes no liability for clinical outcomes resulting from the use of products ordered through this platform.

Sōlix provides a provider platform and sales CRM for ordering regenerative human biologics, managing provider relationships, and integrating third-party services including Google Calendar for scheduling and appointment management. For details on how we handle your data, see our Privacy Policy.

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