The problem
Labelling errors are cheap to make and expensive to find.
A label change touches the regulatory file, the artwork, the printed components and often several markets at once. When review is split across teams, a claim slips through that the data does not support, a symbol appears without its explanation, or a mandatory statement for one market goes missing. The cost arrives later, as a recall, a warning letter or a rejected submission.
Regulatory change has the same shape. New regulations and guidance arrive constantly, and the hard part is not reading them. It is deciding which ones touch your portfolio, what has to change and by when.
We review labelling against the requirements and against the evidence, and we turn regulatory change into an assessed list of actions, each with an owner and a date.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
Labelling review
Drug prescribing information and patient labelling, and device labelling against 21 CFR Parts 801 and 809 and EU MDR and IVDR requirements, checked against the supporting evidence.
What that means for you
- Claims traced to data
- Market-specific statements checked
- Changes linked to the regulatory filing
Artwork and proofing
Review and proofreading of cartons, labels and instructions for use, with version control from draft to print.
What that means for you
- Text compared against the approved source
- Symbols, UDI and barcodes checked
- An approval record for every version
Regulatory intelligence
Monitoring of FDA, EU and other authority publications for the product areas you care about, summarised in plain language.
What that means for you
- Only what is relevant to your portfolio
- A source cited for every item
- Dates you can plan against
Impact assessments
For each relevant change: what it requires, which products and documents it touches, the deadline and the effort.
What that means for you
- An owner and a date for every action
- Input ready for your change control
- Board-ready summaries when you need them
Engagement write-ups appear here only once the client concerned has approved the wording in writing.We do not publish client names or outcomes without that approval.
How it runs
How it runs.
Scope
Products, markets and authority sources agreed, so monitoring and review cover what matters.
Baseline review
Current labelling and open regulatory changes reviewed against the requirements.
Ongoing review and monitoring
Label changes reviewed as they arise and new publications screened on a set cycle.
Actions to closure
Each finding or change tracked through your change control until it is closed.
Questions
Questions we get asked before the first call.
Do you design artwork?
We review and proofread it and manage the version history. Design itself usually stays with your packaging team or agency, and we work alongside them.
Which markets do you cover?
The United States and the European Union in depth. For other markets we confirm the local requirements at the start and tell you plainly where a local partner is needed.
How is regulatory intelligence delivered?
As a regular summary scoped to your products, with every item sourced, plus an impact assessment when something needs action. You can also ask about a specific change at any time.
Is the deadline tracker on your website part of this?
It shows the approach: a short list of dates our clients plan around, each with its source. The service itself is scoped to your own portfolio.
Related
Where to go next.
A label change or a new rule on your desk?
Tell us what it is. A specialist replies with what it touches and what it will take.