How we help

We put the whole portfolio in one place. My US Workspace and My Canada Library hold every label, every version, and the establishments and registrants attached to them — organised, searchable and current. One login, access scoped by division.

Updating takes one of two paths. Minor changes go through the Edit SPL or SPM workflow and the team finishes them in minutes. Extensive changes come back to us as a full package resubmission and we do the rest. Periodic obligations are generated rather than assembled — blanket no-change certification comes out of what the system already knows about the portfolio.

How we help

An approved label is the legally binding instruction for how a medicine is prescribed and taken, and it flows from your submission into DailyMed, electronic health records and pharmacy systems. A wrong dose or a dropped contraindication is not caught by a careful reader — it is executed downstream. So no model writes your label. The pipeline is built for reproducibility: the same input produces the same output every time, and every flagged item points to a specific place in your document.

Benchmark against DailyMed sample #1 (257 pages, 117 tables) published on DailyMed — a public label, not a customer engagement. Pull the same file and check our output against it. Ask us for the run log.

How we help

We watch, so nobody has to remember to. Watchlists track whichever products, applications and obligations matter, and they link straight to the assets in the library — so an alert arrives already resolved to the products it affects, rather than as a notification somebody then has to go and investigate.

What that is worth depends entirely on the business. What each kind of team watches, and why it matters to them, is spelled out on the Who we serve page — innovators, generics, OTC and distributors each have a different reason to care.

How we help

We connected the databases FDA never connected. Ask a real question across them and get a defensible answer in minutes — which generics reference this listed drug, what has changed across a supplement history, where a given ingredient appears across a portfolio.

Different teams ask different questions of the same data. An innovator wants prior precedent; a generics team wants to know which of its products a single approval letter just put on the clock; an OTC team wants to know what is still active across thousands of listings. All three are the same engine pointed at a different question.

This is the capability customers are most surprised to find inside a labeling platform, and the one they end up using daily.

How we help

Reporting is not administration bolted onto the side of submissions. It is a submission obligation in its own right, with its own deadlines and its own consequences for getting it wrong. It gets treated as overhead because the data needed to produce it has always been scattered.

Because the platform already holds the whole portfolio and every version of every label, we generate these reports from what the system already knows, rather than having somebody assemble them by asking around.

If year-end certification is currently a scramble across divisions, this is the pillar that gives you back the most calendar time for the least change in how your team works.

How we help

Audit trails run underneath every action in the platform. Who changed what, when, from which value to which value, and against which version of the label. Not a log you have to go and assemble — a record that is simply there, and that cannot be switched off.

We claim the controls, not the compliance. FDA does not certify software against Part 11 — compliance is established by the regulated company, for its own defined use of the system. What a vendor can do is implement the technical controls the regulation requires and supply the documentation needed to validate the platform. That is what we do, and we say plainly which controls are in place and which are not.