Everyone assumes you have got this handled.
You are the one they come to. That is fine most days. Then something lands that you have not seen before, there is a date on it, and there is nobody in the building you can check it with.
A customer sends a questionnaire
Forty pages, wanted by Friday, and half of it is written for a different kind of operation than yours.
Your co-packer mentions a change
In passing, at the end of an email. The formula is the same, so nobody thought it was worth flagging.
Somebody wants a certificate
One you have never been asked for, from a customer you cannot afford to annoy.
So you look it up yourself
Four contradictory pages. You pick the one that sounds most official and get on with your day carrying a doubt you never quite put down.
The work you finished quietly goes out of date.
A supplier swaps a raw material and does not mention it. A rule behind one of your claims gets rewritten with three years’ notice nobody was reading. The paperwork on your shelf goes on looking exactly as correct as the day it was signed, and there is no alert. Anyone can build you the document. Keeping it true is the part that never has a deadline and never has an owner.
Advisory
Send the question, the document, the email you were not expecting. A straight answer comes back in writing, from someone who already knows how you make your product.
See what this coversForeign Supplier Verification
Most imported food falls under this rule. If yours does, somebody has to do this work and be able to show it. We provide the qualified individual and keep the program current, however many suppliers you end up with.
See what this coversSupplier & Material Qualification
Every supplier and material checked out and kept checked out, the register maintained, and the specifications written from what the qualification actually found.
See what this coversLabel & Claim Review
Every label read against the rules that bind it, and read again whenever you send it back to us. This work is normally priced per label and per change.
See what this coversYou tell us about the place
What you make, who makes it, what you are held to, and what you already have. One guided request, charged once at signup, and everything after it is faster because of it.
You send things
Whenever they turn up. In writing, through your own portal. No calls to book and no standing meeting in your calendar.
It comes back and stays put
The answer lands in your file with what it rested on and the date it was made. Still findable next year when somebody asks how that call got made.
Big jobs get quoted
Sometimes what you send is real work rather than a question. You hear that before anything starts, with a number.
Some of you should not.
Cheaper for both of us if we say so now rather than in week two.
- Something is already happeningAn inspection underway, a records request with a date on it, a shipment sitting at the port. That is a job. It needs quoting, not a subscription.
- You need somebody standing in your plantNothing here includes a visit, at any price.
- You want us to be the quality unitSigning releases, approving batches, holding your responsible-person role. We will not, and paying more will not change it.
- What you really need is one document builtBuy it as a service. It is cheaper, and it will be finished sooner.
- You need someone at nine on a Saturday nightThis runs in writing, in business hours, and we will not pretend otherwise to close a sale.
If a subscription is not the shape of it.
Plenty of what turns up is a one-off. These are the other four doors, and they all finish.
Regulatory work product, not legal advice. Regulatory Support subscriptions provide ongoing access to Regulatory Options for the work each subscription describes. They are not legal counsel, not a certification decision, not a GMP audit, and not your release or disposition decision. We do not monitor your operation, your records, your correspondence or your deadlines, and no deadline is accepted unless we confirm it in writing — sending us a question, a document or a notice does not transfer responsibility for it. What each subscription covers is set out on its own page. Work outside that — a document built from scratch it does not already produce, an investigation, a system assessment, a formal response to an agency — is named as such and quoted before anything starts, and never begun without your agreement. Every answer and determination states what it rested on and on what date, and holds only while those facts remain accurate. Work rests on what you provide and is not independently verified. You remain responsible for your own compliance, decisions, approvals, implementation and submissions. Subscriptions are billed monthly in advance and renew until canceled, with no refund for an unused month, under our Terms of Service and Privacy Policy.