Standards · Regulatory Compliance
Regulatory compliance.
ExoBioCorp is a B2B research-supply distributor. Every product we ship is intended for non-clinical, in-vitro research by qualified scientific personnel. The framework below governs how we operate within the U.S. and international regulatory landscape applicable to research-supply distribution of human-derived cell preparations and extracellular vesicles.
Research Use Only labeling
All ExoBioCorp products are labeled For Research Use Only (RUO) consistent with FDA guidance and 21 CFR 809.10(c). RUO labeling appears on every primary container, on every Certificate of Analysis, and on every shipping document. RUO labeling is not a substitute for downstream-use control; it is the upstream representation we make about the product.
Manufacturer establishment registration
The upstream manufacturers in our supply chain operate under the establishment registration framework applicable to their respective product types, including 21 CFR Part 1271 Subpart B for HCT/P establishments where applicable. Manufacturer registration and inspection records are held by the manufacturer and are referenced on per-product documentation.
Donor eligibility — 21 CFR Part 1271 Subpart C
Where the product chain originates from human donor source material (umbilical cord blood, umbilical cord tissue, etc.), donor eligibility records are held consistent with 21 CFR Part 1271 Subpart C requirements. Donor screening, donor testing, and the documentation chain that supports eligibility determinations are reviewed at lot release.
B2B account verification
ExoBioCorp does not sell to consumers. Catalog access requires verification of B2B research-supply customer status — institutional email, institutional or laboratory identifier, and a brief description of intended research use. Verification is reviewed before catalog pricing is unlocked.
Per-order RUO acknowledgment
Every order requires a per-order Research Use Only acknowledgment, captured in the order record. The acknowledgment confirms that the customer is purchasing the product for non-clinical research purposes and that the product will not be administered to humans or animals for therapeutic, diagnostic, or preventive purposes.
Marketing and promotional constraints
ExoBioCorp marketing and promotional materials operate within the constraints applicable to research-supply distributors:
- No therapeutic claims for any product
- No clinical efficacy claims for any product
- No before-and-after patient imagery
- No patient testimonials
- No disease-specific landing pages
- No representations that a product is FDA-approved or FDA-cleared for clinical use
- No co-promotion arrangements with clinical service providers
These constraints apply to our website, our written materials, our trade-show presence, our digital advertising, and any third-party content we sponsor or syndicate.
FTC promotional considerations
All marketing claims by ExoBioCorp are subject to the Federal Trade Commission's substantiation requirement under Section 5 of the FTC Act, the FTC Endorsement Guides (16 CFR Part 255), and applicable state consumer-protection statutes. We do not present unsubstantiated claims, AI-generated imagery represented as authentic photography, or testimonials without proper disclosure.
Export controls
Where applicable, products are subject to U.S. export administration regulations. International shipments require recipient documentation review. Customers in embargoed jurisdictions may not order from ExoBioCorp.