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Labs That
Set the Expectation

FDA-registered outsourcing facility, licensed to ship nationwide. Equipped with ISO 5, ISO 7, and ISO 8 certified laboratories, we offer flexible, scalable solutions tailored to meet the unique needs of biologics and therapeutic innovations.

Lab scientist
Lab Scientists

Products are manufactured in a controlled laboratory environment designed to support consistency, quality, and regulatory compliance. Every stage of production is performed under defined environmental controls.

Lab vials
Cryogenic vial preparation
10%
Of every batch independently third-party tested prior to release
150+
Controlled lab protocol steps ensuring consistency and viability
3
ISO cleanroom classifications -- Class 5, 7, and 8 certified
GMP
Aligned with 21 CFR Parts 210 & 211 Good Manufacturing Practice
Experience the Difference
FDA-registered outsourcing facility, licensed to ship biologics for office use nationwide under the highest regulatory standards.
Third-party Quality Testing
Viability and Sterility Testing
Controlled Manufacturing and Traceability
Safety, and Product Integrity
Serological Testing
GDUFA Registered
Batch Sizes up to > 100 Vials Overnight
Batch Sizes up to > 250 Vials Three Weeks
Certificate of Analysis (COA)
Accompanies each product shipment
ISO Certified Cleanrooms
Maintained through HEPA filtration, continuous environmental monitoring, and data-driven QA
  • ISO Class 5Aseptic Operations
  • ISO Class 7Processing & Testing
  • ISO Class 8Preparation & Support
21 CFR Regulatory Framework
Aligned with U.S. FDA and international regulatory standards for responsible clinical use
  • 21 CFR Part 58 -- Good Laboratory Practice (GLP)
  • 21 CFR Parts 210 & 211 -- Good Manufacturing Practice
  • 21 CFR Part 820 -- Quality System Regulation
  • ICH International Guidelines
  • European Regulatory Agency Standards

Cold Chain Logistics

All biologics fulfilled through validated cold chain shipping, temperature-controlled directly from partner labs to your door, preserving cellular integrity so products arrive ready for clinical use. Available to all portal members once onboarded with our partner labs.

Let's grow together.

Everything you need to start — provider resources, verified biologics, clinical support, and a structured path to integration.

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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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