The document, built to the standard — or the one you have, reviewed against it.
Fixed-scope regulatory document work you buy outright. Send us what you have and get back a clear, sourced opinion — or have us build the document itself. You own what you get.
Classification & Viability
Which regulatory category a product falls in, and whether its route to market is supportable.
Premarket Safety Filing
The NDI, GRAS, food-additive, or novel-food submission your route requires — built from your records.
Label
Whether a label is complete and consistent with labeling requirements — or the content drafted.
Cosmetic Safety Substantiation
Whether a MoCRA safety file is adequate — or the file itself.
Process Validation / PPQ
Whether a process validation is complete — or the protocol to run it.
Method Validation
Whether a method validation is assessed against USP and ICH — or the protocol to run it.
Equipment Qualification
Whether IQ/OQ/PQ qualification is sound — or the protocol to run it.
Cleaning Validation
Whether a cleaning validation is adequate — or the protocol to run it.
From your file to your finished deliverable — the whole path.
You buy the service, and a guided intake takes it from there — it asks only for the documents the work needs and the questions it actually raises, the same way every time.
The whole process, start to finish.
Presenter and voice are AI-generated.
Choose your service and buy
Pick the service, set the depth, and pay. One price, the same for everyone.
A guided intake, not a file dump
You get a private, secure upload link by email. It walks you through each document we need, one at a time, and asks the clarifying questions the work actually requires — and no more than that. The scope is set by the work, not fished for — that’s how the price stays fixed and the turnaround stays consistent.
We check what you sent
Before anything starts, a real person confirms each document is the right one and is usable.
Approved — and the work begins
The moment your documents are approved, your work starts and the turnaround clock begins. Not a day before.
You get your finished deliverable
Whatever the service produces — an opinion, a drafted document, a regulatory response — written for your file and ready to put to use.
We hold the slot. You bring the file.
So the process stays fast and fixed-price for everyone, a few things are firm — stated up front, never buried.
- Documents must be in English. Non-English documents need a certified English translation before the review can run.
- The work starts at approval — when your documents are confirmed complete and usable, not at purchase.
- You have 14 days to upload and get your documents approved. After that the order closes and isn’t refunded — no reschedule.
- Your files stay yours. They’re used only to produce the service you bought, shared only with the people and tools needed to do the work, never sold, and handled under our Privacy Policy.
- Not legal advice. This is professional regulatory work, not legal advice, and doesn’t guarantee any agency, audit, or certification outcome. The final call on your product stays yours.
Each service tells you precisely which documents it needs, and the depth you choose determines how many. These are the common ones — click any card to open a real example. Every document we might request is explained in full on the Records page.
The document is the start — not the whole job.
Each service answers one question. When you want to know where you stand, put the whole system in place, or get your team up to speed — here’s where it goes next.