Clinic launch guide
Qualifying a Supplier Before the First Order
Reviewed by ExaVeyra Sciences editorial team · Updated 29 August 2026
ExaVeyra Sciences is a Miami-based B2B supplier of research-use exosomes and 503A compounded peptides to licensed clinics.
| Question | Answer |
|---|---|
| What this is | The documentation to request from a supplier, what a certificate of analysis can and cannot tell you, and the receiving checks that belong in an SOP. |
| Who can buy | Licensed clinics and practitioners, after ExaVeyra verifies an active professional license and NPI and, for exosome material, a signed research-use acknowledgment. |
| What ships or is provided | Research-use exosome formats, 503A compounded peptides prepared to prescription by our 503A pharmacy partner, and PRP devices, through one verified account. A certificate of analysis is issued for every lot and provided on request. |
Most practices qualify a supplier after the first order, by noticing what went wrong. The documents that would have told you in advance are the same ones a supplier can produce in a day if they have them, and cannot produce at all if they do not.
This page is the request list, what each document is actually evidence of, and the receiving checks worth writing into a procedure. It is written to be useful whoever you buy from.
Ask during pricing, while it is a routine question
Documentation requested during pricing is a routine question. The same request made after an invoice reads as a complaint, and it arrives when you have least leverage and most urgency.
There is a practical reason beyond leverage. A supplier who holds these documents can send them within a business day, because they are already assembled for their own quality system. A long delay is itself an answer.
The documents that matter, and what each one proves
Each row below is a document a legitimate supplier can produce on request. The right-hand column is the part worth internalising: a document proves a narrower thing than its name suggests.
| Document | What it is evidence of | What it does not establish |
|---|---|---|
| Certificate of analysis, lot specific | That the named tests were run on that lot and what the results were. | Anything about a different lot, or about attributes nobody tested. |
| Sterility and endotoxin reports | That the batch was tested for contamination by a stated method. | Sterility of a container opened outside the supplier’s control. |
| State licensure for your destination | That the pharmacy or distributor may ship into your state. | That the preparation itself is permitted for your intended use. |
| Compounding chapter conformance, USP 795 and 797 | The standard the preparation was made to, non-sterile and sterile respectively. | FDA approval, which compounded preparations do not have. |
| Storage and shipping conditions | The range the material is qualified to hold, and how it was shipped. | That the range was held in transit, unless a monitor travelled with it. |
| Documented recall and complaint process | That a route exists to reach you if a lot is withdrawn. | That it has ever been exercised. Ask when it last was. |
Read a COA by its test list first
The most common misreading of a certificate of analysis is treating the absence of a result as a pass. A COA reports the assays that were run. An attribute nobody measured does not appear, and its absence looks identical to a clean result to anyone skimming.
So the first pass is to read the test list rather than the values: what was measured, by what method, against what specification. Reading the values themselves is a longer subject, and there is a dedicated guide to it linked below.
Put the receiving checks in a procedure
Qualification does not end at the first order. The checks below take a few minutes at delivery and are the ones that catch a problem while it is still returnable and still attributable to the shipment.
- The lot on the container matches the lot on the paperwork. A mismatch is a stop, not a note.
- The beyond-use or expiry date leaves useful life for the way you actually use the product.
- Cold-chain shipments arrive within their stated range, with whatever monitor was agreed still readable.
- The container closure is intact and the label is legible, including the lot and the date.
- The certificate for that lot is on file before the material is used, not after.
Writing these down matters more than the checks themselves. A procedure survives staff turnover and produces a record; a habit does neither, and it is the record a state board or an auditor asks for.
Tennessee shows where the floor is heading
Tennessee Public Chapter 1016, effective 1 July 2026, is the first US statute to name exosome-based regenerative products, and it does so by setting a supplier documentation standard: particle counts, a lot-specific sterility report and a certificate of analysis.
It is a documentation requirement rather than a product approval, and that is the useful part. A practice already asking for the rows in the table above is most of the way to satisfying it, in Tennessee and in whichever state writes the next one.
Questions that separate a supplier from a reseller
These four are worth asking directly, because the answers are hard to improvise and they distinguish a supplier who controls their chain from one who forwards a box.
- Who manufactures this, and can you name them to a verified account?
- What is the shortest beyond-use date I could receive on a normal order?
- When did you last issue a recall or a field notification, and how were customers reached?
- Which of these documents do you hold on file today, and which would you have to request from someone else?
A supplier who answers the last one honestly, including the parts they have to request, is telling you where their chain actually ends. That is more useful than a supplier who claims to hold everything.
How wholesale access actually works
Qualification runs in both directions. A supplier selling prescription and research-use material to practices verifies who is buying, which is why wholesale pricing and formulary detail sit behind a check rather than on a public page.
For ExaVeyra, that check is NPI verification. Completing it opens wholesale pricing, the pharmacy formulary and the lot-specific documentation described above, and it is a single step rather than a per-order approval.
Sources
- FDA, Section 503A of the Federal Food, Drug, and Cosmetic Act (accessed 29 August 2026)
- FDA, Understanding the risks of compounded drugs (accessed 29 August 2026)
Scientific literature
Each source carries the kind of study it was and, where the study enrolled people, how many. Study design decides what a result can establish, so it is stated rather than left to be inferred. Each line also says what that source is carrying on this page.
- Welsh JA, Goberdhan DCI, O’Driscoll L, et al. Minimal information for studies of extracellular vesicles (MISEV2023): from basic to advanced approaches. Journal of Extracellular Vesicles, 2024. doi:10.1002/jev2.12404 PMID:38326288Consensus statementLandmarkSource 1 supports: The field-specific reporting standard for vesicle preparations. Cited here because it is a published standard a purchasing practice can hold a supplier to without relying on the supplier’s own framing of what counts as adequate characterisation.