cGMP-Aligned · FDA-Registered U.S. Facility · Third-Party COA on Every LotSupplied for Research Use Only
Quality & Sourcing

Held to a manufacturer’s standard.

Every lot is produced under cGMP-aligned processes and released with third-party characterization — so your research begins with material you can trust.

01

cGMP-Aligned Manufacturing

Produced in an FDA-registered U.S. facility under controlled, documented processes.

02

Third-Party COA

Independent verification of identity, particle count, concentration, sterility, and endotoxin — on every lot.

03

Wharton’s Jelly Source

Ethically obtained, screened MSC source — characterized and traceable.

04

Particle Characterization

NTA, TEM, and flow cytometry confirm size distribution and vesicle identity.

05

Cold-Chain Integrity

Temperature-controlled logistics preserve material from facility to delivery.

06

Research Use Only

Supplied strictly for research; not FDA-approved to diagnose, treat, cure, or prevent disease.

Request Documentation

See the paperwork.

Request a sample Certificate of Analysis and characterization data for your team to review.

Request a COA

Important Information

These statements have not been evaluated by the U.S. Food and Drug Administration. BioRegenEx products are not intended to diagnose, treat, cure, or prevent any disease.

Exosome therapy is an emerging regenerative approach. It is investigational, outcomes vary, and individual results cannot be guaranteed. Patient testimonials reflect individual experiences and are not representative of typical results.

References to regulatory standards — including Section 351(a) of the Public Health Service Act — describe the company’s stated quality and compliance approach and should not be interpreted as FDA approval or endorsement of any product.

This presentation is provided for educational and informational purposes only and does not constitute medical advice. Treatment decisions should always be made in consultation with a qualified, licensed healthcare provider.