Regulatory Support

Your suppliers, and what you actually buy from them.

Every supplier and every material checked out and kept checked out — with the register maintained, the review dates watched, and the specifications written from what the qualification actually found.

All Regulatory Support subscriptions

What this is

Approving a supplier is easy. Keeping them approved is the job.

Knowing what you are buying, and being able to show it, sits with you. Most operations manage that once, at the start, and then the file ages quietly. A certificate expires. A supplier moves production to a second site. Somebody adds a material because purchasing found it cheaper, and nobody tells quality until an auditor asks where it came from.

None of that is negligence. It is what happens to a file nobody is assigned to keep, in a company where the person who would keep it already has another job.

Supplier & Material Qualification

We run the approved supplier program — the qualification, the register, the review dates and the specifications — and keep it true as you add and change things.

What this covers

Qualification of every supplier — what they are approved for and on what basis
Qualification of every material — down to the grade and the source, not just the name
The approved supplier register — built, maintained, and ready to hand over
Written specifications — for each material, from what the qualification actually found
Documents read properly — certificates, audit reports, questionnaires, test data
Review dates watched — so you know what is due before it lapses
New suppliers and materials — qualified as you add them, at no extra charge
A written conclusion on each — what it rests on, what is missing, when it is next read
Not foreign supplier verification — if you import food, that is a separate program and its own subscription

The specifications are included, and that is unusual

Qualifying a material means reading its certificate, its technical data sheet and its allergen statement. The specification falls out of that reading — so you get both documents from one piece of work, written from the same evidence, saying the same thing. They are usually separate purchases, and when they disagree with each other it is generally because they were written by different people at different times.

When it turns out to be bigger

Qualifying what you have and what you add is the subscription. Rebuilding a supplier program that does not exist, running a supplier audit, or investigating a material that has already caused a problem is a project. You hear that before anything starts, with a number.

What this catches

Three approved suppliers, and what approval was actually resting on.

Constructed examples. The companies are invented; the failure modes are ones that turn up in real supplier files.

Approved on a questionnaire nobody read past page one.

Reads asA completed supplier questionnaire, signed and dated, filed against an approved supplier.

Hiding in itQuestion fourteen says they subcontract the drying step. Nothing in the file says to whom, and the approval covers a company that never touches the material at that stage.

Why it mattersYou have approved the company you buy from rather than the operation that makes it. The first time that matters is the first time something goes wrong at a site you never knew existed.

The specification was written from the sales sheet.

Reads asA specification on file for every material, each with limits and methods.

Hiding in itThe limits were copied from the supplier’s marketing document. The certificate that arrives with each lot tests different things, by different methods, at different limits — so nothing that arrives can actually be checked against the specification you hold.

Why it mattersA specification you cannot verify against is a document, not a control. For a dietary supplement operation these are two separate duties in the rule — establishing what a component must be, and determining that it is met — and they only work together if the two documents were written to each other.

21 CFR 111.70 · 21 CFR 111.73

Requalification was annual, and the year quietly passed.

Reads asA procedure saying suppliers are requalified annually, and an approved supplier list with no expired entries on it.

Hiding in itThe list has no dates on it. Requalification is somebody’s calendar reminder, and that somebody left in March.

Why it mattersA procedure that says annual and a record that cannot show when is worse than no procedure at all — you have written down the standard you are failing to meet.

Setup, priced once by the size of what has to be established

Up to 10 suppliers

$4,000

One-time

11 to 30 suppliers

$7,500

One-time

Over 30 suppliers

$12,000

One-time

Tap the band that matches you. It sets how many we establish at the start — a smaller band costs less and takes longer to work through.

Setup builds the register from what you already have. After that the monthly fee does not move, however many suppliers and materials you add — this work is normally priced per supplier, per material, and per document read.

Due today$4,000Setup for up to 10 suppliers · then $2,500 per month
Any number of suppliers and materials · billed monthly in advance and renews automatically each month until you cancel
Cancel any time before your next renewal · no refund for an unused month

Common questions

Straight answers.

Do you chase our suppliers for documents?

No. You send us what the supplier gives you, or you introduce us and we ask in writing with you copied. Where a supplier will not produce what qualification needs, that is a finding about the supplier and a decision for you.

What if we send you forty suppliers at once?

Then it takes longer than four. The fee does not change and the work gets done in the order it arrives. What we will not do is pretend a large first batch comes back as fast as a small one.

Who approves the supplier in the end?

You do. We produce the qualification and the written conclusion — what it rests on, what is missing, what would change it. Authorising a supplier for use is your decision and stays yours.

Are the specifications really included?

Yes, for every material we qualify. They come out of the same documents the qualification reads, which is why they agree with each other. Reworking a specification you already hold and want kept is included too; building a specification for something we have not qualified is a separate piece of work.

Does this replace a supplier audit?

No. This is the documentary program — qualification, records, specifications, review dates. Going to a supplier’s site and auditing it is a different thing, it is quoted separately, and nothing here includes a visit.

Is this legal advice?

No. It is regulatory work product. It does not guarantee what an agency, an auditor, a certification body or a customer decides, and where something looks to us like a question for a lawyer, we say so.

The rest of the pillar

Most companies hold more than one.

Regulatory work product, not legal advice. Supplier & Material Qualification produces qualification records, specifications and a maintained register from the documents you and your suppliers provide. It is not legal counsel, not a certification decision, not a supplier audit, and not your approval or release decision — authorising a supplier or a material for use remains yours. No site visit is performed at any price. We do not monitor your purchasing, your incoming material or your correspondence, and no deadline is accepted unless we confirm it in writing; sending us a document does not transfer responsibility for it. What this subscription covers is set out above. Work outside it — rebuilding a supplier program that does not exist, auditing a supplier, or investigating a material that has already caused a problem — is named as such and quoted before anything starts, and never begun without your agreement. Every conclusion states what it rested on and on what date, and holds only while those facts remain accurate. Nothing supplied is independently verified. You remain responsible for your own compliance, decisions, approvals, implementation and submissions. Companies and situations shown as examples are constructed; no real company is depicted. Billed monthly in advance and renews until canceled, with no refund for an unused month, and setup is charged once at signup, under our Terms of Service and Privacy Policy.