Your specification, reviewed or built from scratch.
Two ways in. Have a spec? Get an independent written opinion on whether it holds up, at the depth you choose. Need one? Send your product basics and we build a defensible specification, with methods fit to detect what it sets.
For more than a decade, the single most-cited FDA inspection finding for supplement makers has been the same one: failure to establish or verify product specifications under 21 CFR 111.70(e). It was the top Form 483 observation again in 2023 and 2024.
Whether your specification holds up, against the rules and against what backs it.
A specification is the set of limits and methods that defines what your product is and proves it conforms. It can be raw-material, finished-product, or in-process. We judge the one you hold, or build the one you’re missing, against the compendial and regulatory requirements and against your own records. That means more than checking whether the limits and methods read correctly. It means checking whether the spec reconciles to your manufacturing record, whether your data meet it, and whether the methods can detect what the spec sets.
Specifications Opinion Letter
An independent regulatory opinion on a specification you already have: does it hold up? Start at the base, and add a record to take the opinion deeper.
- Raw-material / ingredient specifications
- Finished-product specifications
- In-process / control-plan specifications
- Identity & purity (USP / compendial)
- Contaminant & heavy-metal limits
- Banned-substance screen
- Supplier spec adequacy
- Test-method fitness for specified limits
A signed written opinion. File it in your quality system, hand it to an auditor or a customer, or use it to fix a gap before an inspection instead of after. Each limit and method is read against the rule and the compendial requirement, with a clear conclusion and what it would take to address it. Not a label check that never looks at the spec, not spec software that stores it without judgment, and not the consultant grading work they helped write. A fixed-price independent read that surfaces the spec that reads complete and falls apart the moment someone asks what backs it.
A worked specification, and what the base review alone surfaces.
This is the $950 base: the spec read on its face, before a single other record. Hover or tap a marker to read the finding. The deeper add-ons bring in the records that catch what a spec sheet alone can’t.
If your spec can’t be given a clean opinion on what you send, you get a straight report on what’s missing instead, at the same fee.
Specifications Development
No defensible spec yet? Send your product basics and we build the specification from scratch. One flat fee, with limits your product can hold and methods fit to detect them.
- Raw-material / ingredient specifications
- Finished-product specifications
- In-process / control-plan specifications
- Identity & purity (USP / compendial)
- Contaminant & heavy-metal limits
- Banned-substance screen
- Test-method fitness for specified limits
The built specification, ready to issue and test against: parameters and limits, identity and purity, contaminant and banned-substance limits, and the methods to verify each. It is set against the compendial and regulatory requirements and grounded in what your product is, not copied from a supplier sheet or a generic template. Built to be defensible on its face and backed by methods fit to detect what it sets. Where the product can’t meet a defensible spec as it stands, we tell you that plainly and give you the path to fix it, at the same fee. Never a number written to look right.
The basis we build from: what the product or ingredient is, how it’s made and used, the claims it has to support, and any formulation, supplier, or test data you already have.
The same ingredient, with a spec that has to hold. The calls we’d make, and why.
Nothing to catch on a build. You send what it is, how it’s made, and the data you have, and the reasoning is the work. Here is the same constructed bulk CBD isolate, brought to us to build a defensible specification from scratch, and the call we’d make on each line.
Straight answers.
Isn’t my spec fine if it passes my own testing?
Passing your testing only proves the product met the limits you set. It doesn’t tell you a limit is missing, that a method can’t detect what you specified, or that a number was taken on a supplier’s certificate. Those are the gaps that pass your checks and fail an audit, and they’re what this reads for.
Doesn’t my spec software already handle this?
Software stores the spec; it doesn’t judge it. It will hold a limit nothing tests for and a method that can’t see the analyte without ever telling you it can’t be defended. This is an independent read of whether the spec holds, the part software can’t do.
Can’t the consultant who wrote my spec just check it?
They can, but they’d be grading their own work, and usually inside an open-ended engagement. This is a fixed-price verdict from someone who didn’t write the spec and has no testing to sell you on the back of it. That independence is the point.
How deep does the review go?
As deep as you want. The base reads the spec on its face. Add your manufacturing record and we reconcile the spec to how the product is defined. Add the certificate of analysis and the batch record and we check whether your data support the limits and whether the lot was made to them.
What if my product can’t meet a defensible spec?
You get told that plainly, at the same fee. On the review it comes as a finding; on the build it comes as the honest path to fix it. We lay out the options and you decide. We don’t write a number to look right and we don’t make the call for you.
Is this legal advice?
No. It is an independent regulatory opinion or a built work product, not legal counsel, and it creates no attorney-client relationship. If your question is whether your specification holds up against the rules and the records behind it, that is ours.
Where to go from here.
Once you know whether your spec holds, here’s where it goes next.
Regulatory work product, not legal advice. A deliverable is prepared from the records you submit and is not legal counsel, not a guarantee of any regulatory or customer outcome, and forms no attorney-client relationship. It is prepared for your own use; any reliance by an auditor, a customer, or another third party is at their own risk and creates no duty to them absent a separate written agreement. The review is a document review, not a GMP audit, not analytical testing, and not the disposition or release decision. The build produces the specification and specifies methods as fit for purpose; it does not validate methods in the lab, run the testing, or determine legal status. Where the records provided can’t support a defensible result, we deliver a findings report on what’s missing instead. High Desert Botanical Extracts / GMPure™ is a constructed teaching case; no real company or product is depicted.