Most companies find out whether they can answer during the recall, not before it. This audit tells you in 14 days — in writing, on your real products.
Wholesale distributors: 1 business day, not to exceed 48 hours — 21 U.S.C. §360eee-1(c)(1)(C). Dispensers: 2 business days — §360eee-1(d)(1)(D).
A drug gets recalled. Or FDA opens an investigation into a suspect product and one of your lot numbers is on the list. Someone calls you and asks a simple question: where did this unit come from, and where did it go?
The law gives you two days to answer. Not two days to start looking — two days to have the answer.
It has the numbers. Whether it can assemble one unit's full history, across every partner who touched it, inside 48 hours is a different question — and almost nobody has tested it.
The record exists, but in pieces: your system, your supplier's portal, an emailed file, a PDF someone saved. Assembling it is a research project. The clock does not care.
When you cannot say exactly which units are affected, you pull everything that might be. Good product goes in the bin because the record could not be trusted to be precise.
DSCSA is not coming. It arrived. The stabilization period ended in November 2024 and FDA's exemptions have expired for every category except the smallest pharmacies. If you are a wholesale distributor or a larger dispenser, you are already inside enforcement.
There is one clock left, and it is not yours unless you are small: 27 November 2027.
We pick one of your real products. We ask the question a regulator would ask. Then we time you.
A real product from your real inventory. We follow it back through every hand it passed through, using only the records you actually hold today.
You get a number: how many hours it takes you, today, to answer the question the law gives you 48 hours to answer. Most people have never measured this.
Every gap, what it would cost to close, and how long it takes. Ranked, so you can fix the dangerous ones first and argue about the rest later.
That is the whole product. There is no platform you have to buy to get value from it, and no rip-and-replace. If your existing systems come out clean, the report says so.
Pay online and we start. If you go on to implement with us, the full $5,000 comes off your first invoice — so the audit costs you nothing but time. If you don't, you keep the report and owe us nothing further.
DSCSA is where US pharma starts. If you sell into Europe, the same method applies to the rules that reach you there.
Can you trace one unit, end to end, in 48 hours? We measure it, then tell you what to fix.
Book this audit → EU Pharma · 2011/62/EUWhere a copied barcode would pass your checks, and what closes that hole.
Start this audit → Reg. 2023/1542 · 18 Feb 2027The first product passport with a hard date. Article 77 identity from cell to second life.
Start this audit → ESPR 2024/1781 · 2027–2030Carrier readiness and whether the physical anchor survives the product's life.
Start this audit → Reg. 2023/1115 · 30 Dec 2026Plot-level origin and due-diligence readiness for cocoa, coffee, timber, palm, rubber and soy.
Start this audit → Custom · DFARS · CMMC · TatmeenForced Labour Regulation, DFARS 252.246-7008, CMMC, UAE Tatmeen, or a mandate not listed here.
Start this audit →
In the field · pallet-level verification
$5,000, fixed, paid online. If you go on to implement with us, the full $5,000 comes off your first invoice — so the audit costs you nothing if you proceed. Larger multi-regulation scopes are quoted after a short call.
A written report in 14 days: where you are exposed under the regulation, a timed test of how fast you can trace one unit today, a fix list with costs and dates, and a scoped pilot for one product line. It is written to be handed to a regulator or a board, not to a salesperson.
If you are a wholesale distributor: 1 business day, not to exceed 48 hours (21 U.S.C. §360eee-1(c)(1)(C)). If you are a dispenser: 2 business days (§360eee-1(d)(1)(D)). The clock starts when the request arrives, not when you find the records.
Yes. The stabilization period ended 27 November 2024. Manufacturer exemptions expired May 2025, wholesale distributors August 2025, larger dispensers November 2025. Only small dispensers have time left, until 27 November 2027.
No, and we would tell you if you did. Those systems do serialization and they do it well. We test whether the data they hold can actually answer a regulator's question in the time the law allows, and we sit on top of them rather than replacing them.
No. It is a standalone engagement with a written deliverable and no obligation. Plenty of people buy it purely to size their exposure and stop there. That is a legitimate outcome and we will not chase you.
Then you have a dated written record saying so, which is worth having the next time your board or a customer asks. We will not invent a gap to justify the fee, and the report says plainly what it found.
Our audit team, working from your existing records and systems. Expect two calls and a data pull — usually under four hours of your people's time across the fortnight.
