Where Science Meets
Uncompromising Standards
At OmniGenix, quality is engineered into every molecule. From raw material sourcing through final lot release, our multi-layered quality system ensures every product — including our exosomes, stem cells, and peptides — meets the rigorous demands of modern clinical practice.
Across All Products
& Documentation
Per Production Run
Monitoring
Built on Three Pillars of Excellence
Every OmniGenix product — whether exosomes, stem cells, or peptides — is governed by a quality framework designed not merely to meet industry standards — but to redefine them. Our approach integrates pharmaceutical-grade manufacturing, analytical rigor, and complete supply chain transparency across our entire product portfolio.
Pharmaceutical-Grade Manufacturing
All products are manufactured in ISO-classified cleanrooms operating under cGMP protocols. Environmental controls, personnel gowning, and documented procedures ensure batch-to-batch consistency that clinicians can rely on.
Analytical Verification
Every lot undergoes a comprehensive battery of analytical tests — including HPLC purity analysis, LC-MS/MS identity confirmation, sterility, endotoxin, and potency assays — performed by accredited third-party laboratories.
Complete Traceability
From raw material sourcing through patient delivery, every touchpoint is documented and auditable. Our chain-of-custody system provides full visibility into every component, process step, and quality decision made along the way.
From Source to Your Clinic
Every OmniGenix product — from exosomes and stem cells to peptides — passes through a documented, multi-stage quality pipeline before it ever reaches a patient. Here's what that looks like.
Ethical Sourcing & Raw Material Qualification
All biological materials are sourced from rigorously screened, consenting donors following full-term, healthy births. Raw materials undergo incoming quality inspection against predefined acceptance criteria before entering the manufacturing pipeline.
- Full informed donor consent
- Comprehensive infectious disease panel
- AATB-accredited tissue banks
- Raw material identity verification
GMP Manufacturing & Process Controls
Products are manufactured in ISO 7 / Class 10,000 cleanrooms under strictly controlled environmental conditions. Every process step follows validated standard operating procedures with real-time environmental monitoring.
- ISO 9001:2015 certified facilities
- Real-time particle monitoring
- Validated SOPs for every step
- Documented batch records
Analytical Testing & Lot Release
Before any lot is released, it undergoes a full analytical panel performed by independent, accredited laboratories. Results are documented in a Certificate of Analysis (COA) that accompanies every shipment.
- HPLC purity analysis (≥98%)
- LC-MS/MS identity confirmation
- USP sterility & endotoxin testing
- Potency & viability assays
Cold Chain Logistics & Secure Delivery
Product integrity is maintained from facility to clinic through validated cold chain logistics. Shipments travel in insulated containers with continuous temperature monitoring to ensure stability upon arrival.
- Temperature-controlled storage
- Insulated shipping with ice packs
- Continuous climate monitoring
- Tamper-evident, sealed packaging
Industry-Leading Standards
Our manufacturing partners and laboratories hold the most demanding certifications in the biologics and pharmaceutical industries.
cGMP Compliant
Current Good Manufacturing Practice protocols across all production facilities
ISO 9001:2015
International quality management system certification for manufacturing operations
AATB Accredited
American Association of Tissue Banks accreditation for biological tissue sourcing
Every Lot. Every Test. Fully Documented.
We believe transparency is the foundation of clinical trust. That's why every OmniGenix product — across our exosome, stem cell, and peptide lines — ships with a comprehensive Certificate of Analysis detailing the complete analytical profile for that specific lot.
- Lot-specific COA included with every shipment
- Full analytical data — not just pass/fail summaries
- Independent third-party laboratory verification
- Digital COA archive accessible via your clinic portal
- Batch genealogy traceable from donor to delivery
Commitment to Regulatory Compliance
OmniGenix operates within the full scope of applicable regulatory frameworks. Our stem cell products are processed and distributed in accordance with FDA 21 CFR Part 1271 as 361 HCT/P products, and our manufacturing partners maintain all required state and federal registrations.
Our exosome products are derived from an FDA-approved cell line, ensuring the highest level of regulatory confidence and manufacturing consistency. Additionally, our exosomes are sourced exclusively from a pre-COVID donor, meaning the biological material is entirely free of SARS-CoV-2 spike proteins and related contaminants — providing clinicians and patients with added peace of mind regarding product purity and safety.
We maintain comprehensive documentation practices that support clinical transparency and provide the audit trail that institutional review processes require. Our regulatory affairs team is available to assist with compliance questions, provide additional documentation, or support your practice's internal review procedures.
Questions about compliance or regulatory documentation? Our team is standing by to support your due diligence process.
Quality You Can Verify
See the OmniGenix difference for yourself. Request a sample COA, tour our facilities, or speak with our quality team directly.
We welcome the scrutiny — because our products are built to withstand it.
Invest in Tomorrow’s Medicine—Partner with OmniGenix!
Contact Us
Call Us
+1 (888) 553-4777
Email Us
support@omnigenix.com
Working Hours (PST)
Monday ————- 7:00 – 5:00
Tuesday ————- 7:00 – 5:00
Wednesday ——— 7:00 – 5:00
Thursday ———— 7:00 – 5:00
Friday —————- 7:00 – 5:00
Questions?
We would be happy to answer any questions you might have about our MSC exosome products. You may call, email, or schedule a product consultation appointment at your convenience.