Skip to content
For co-packers & contract manufacturers

You don’t run one regulatory program. You run one for every customer on the floor.

A contract manufacturer with 50 customer SKUs is carrying 50 sets of specs — and the regulatory rules behind each one move on their own schedule, in their own category, in whatever states that brand ships to. Mirelis monitors federal and state regulatory change across the categories your customers actually sell in, lets you filter the view down to a single customer, and gives you a clean slice to drop into a procurement or quality thread. One system, every customer, the record to prove it.

The problem

Every customer’s category has its own moving rules.

When you make product under someone else’s brand, you inherit their regulatory exposure without inheriting their regulatory staff. The bakery line, the beverage line, the supplement line, and the snack line on your floor are governed by different federal requirements and different state laws — and each of your customers expects you to be current on the rules that touch the product you ship for them.

Many categories, no single scope

A general regulatory feed isn’t scoped to you — it’s scoped to everything. Most of what lands doesn’t touch a single SKU you run, and the few items that do are buried in the rest. The work isn’t reading the feed; it’s figuring out which line on your floor each change actually hits.

Every customer ships to different states

Federal rules are only half of it. One customer sells into a handful of states; another is national. State legislatures move on additives, disclosures, and labeling on their own timelines — so the map of what matters is different for each brand you produce for, and it changes underneath you.

The update has to leave your inbox

Knowing a rule changed isn’t the deliverable. Procurement has to re-check a supplier spec; quality has to update a control; the customer’s brand team needs a heads-up. If that hand-off lives in one person’s head or one person’s inbox, it doesn’t survive a vacation, a reorg, or an audit.

None of this is hard because the information is secret. The federal and state sources are public. It’s hard because the volume is high, the relevance is low, the scope is different for every customer, and the answer has to reach more than one desk. That’s a sorting-and-routing problem, run continuously, across a portfolio — and it doesn’t fit neatly on anyone’s existing job.

Why the usual tools miss this

A directory tells you a rule exists. A PLM system tracks your specs. Neither watches for what just changed for a given customer — and hands it to you to send.

Regulatory directories and reference libraries are built to answer “what is the rule today.” They’re reference works. They don’t watch for the moment a rule moves, and they don’t know which of your customers that movement touches.

Product-lifecycle and supplier-network tools are built around your documents — specs, certificates, supplier records. They’re good at that. But they’re not watching state legislatures or the Federal Register, and they don’t turn a regulatory change into a routed, shareable alert scoped to one brand on your floor.

What a co-packer needs sits in the gap between the two: monitoring of regulatory change, scoped to the categories and states each customer actually operates in, that produces a slice you can hand to the people who have to act on it. That intersection is what the Mirelis Regulatory Horizon Tracker is built for.

The workflow

Filter to one customer. Share the slice. Keep the record.

The tracker monitors active federal and state regulatory developments across FDA, USDA, FTC, TTB, with daily change-detection on state legislative activity nationwide — normalized, de-duplicated, written in plain English, each item tied to its primary source and its compliance date. For a co-packer, three things matter most about how that runs.

A filtered view per customer

Build a saved view for each brand you produce for — scoped to the categories that customer sells in and the states they ship to — so “what’s moving for this account’s products” is a view you open, not a sort you redo every week. The portfolio stops being one undifferentiated feed and becomes a shelf of per-customer lenses.

A shareable change alert, scoped tight

When something in a customer’s scope changes, you get the filtered slice — the rule, the plain-English summary, the primary-source link, the compliance date — and you can put exactly that in front of procurement, quality, or the customer’s brand team. They see only what touches that account, with the source attached, not a forwarded firehose they have to re-filter themselves.

An audit trail you didn’t have to assemble

Because each item carries its source and its date, “when did we know, and what did we do” stops being an email archaeology project. When a customer’s auditor — or your own — asks how you stay current on the rules behind their product, you have a defensible answer scoped to that account, not a shrug and a promise to dig.

This is the part the directories and the PLM tools leave to you: the routing. A change is only handled once it reaches the person who acts on it, with enough context to act and enough record to prove it later. Scoping the view to one customer and handing off a clean slice is how a small team covers a portfolio that would otherwise need a regulatory desk per account.

Built for more than one desk

A regulatory change at a co-packer rarely stops at one person. The tracker is priced for the team it actually reaches.

A change moves between whoever watches the rules, procurement re-checking a supplier spec, and quality updating a control. The Team tier is built for exactly that hand-off: multiple seats on one account, with shared saved views so the per-customer lenses you build are the same ones your colleagues open — not private filters that live and die with one login.

It also includes a monthly regulatory digest and priority on update requests, so when one of your customers operates in a category or state the tracker should watch more closely, you can ask for it. The point isn’t a longer feature list. It’s that the people who have to act on a change are all looking at the same scoped view, with the same sources, at the same time.

Mirelis is invite-only while we onboard our first cohort. “Request access” routes to a short conversation, not a checkout.

Start with the labels you already run

Not sure where your exposure is? Start with a supplier-readiness review.

If you’d rather see the gaps before you subscribe to anything, we’ll do the first pass with you. A supplier-readiness review walks a representative set of the SKUs you produce — the labels, the claims, the categories, the states they ship to — and gives you back a prioritized read on where your current customers’ products are most exposed to regulatory change, and what to watch first. It’s the same lens the tracker runs continuously, done once, by hand, on your actual portfolio.

It’s also the cleanest way to decide whether the tracker earns its place in your operation: you see the real exposure on real product before you commit to monitoring it.

Book a supplier-readiness review

A one-time, hands-on read of where your customers’ products sit against the moving regulatory landscape.

Start the conversation
Why this is a now-problem, not a someday-problem

The rules your customers depend on are already on the clock.

Consider one rule that lands squarely on contract manufacturers: the FDA Food Traceability rule under FSMA 204. Facilities that manufacture, process, pack, or hold foods on the Food Traceability List will need to keep and share specific traceability records, and the date that matters is July 20, 2028 — the point before which FDA has been directed not to enforce the rule. (FDA has separately proposed to move the rule’s own compliance date to that same date; that rulemaking is not yet final, but the enforcement date is set either way.) For a co-packer, that obligation doesn’t arrive once — it arrives per customer, per qualifying product, with recordkeeping that has to line up across your suppliers and your customers’ brands.

That’s a single, well-defined example. The reason monitoring matters is that it’s rarely the rule you already know about that catches you — it’s the state bill in a market one of your customers just expanded into, or the federal change that quietly reset a deadline. Seeing those early, scoped to the right account, is the whole job.

Go deeper on this one

FSMA 204 readiness, in eight pillars

Our FSMA 204 Readiness Checklist walks the runway to the 2028 enforcement date across scope, CTEs, KDEs, traceability-lot codes, data carriers, the plan, partners, and a mock traceback — with primary-source citations throughout.

Get the FSMA 204 guide

Continuous monitoring, scoped to your floor

One customer’s rules are a project. Fifty customers’ rules are an operation.

The Mirelis Regulatory Horizon Tracker runs that operation for you — monitoring federal and state regulatory change, scoped to the categories and states your customers actually sell in, with per-customer views, shareable change alerts, and a monthly digest. Invite-only while we onboard our first cohort.