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Regulatory excellence
Labelling
From the company core data sheet to approved national product information, labelling is one long chain of dependent documents in many languages. We manage the whole chain, and we automate the parts of it that should never have been manual.
Why it matters
The label is where every function meets
A single safety change to a core data sheet can cascade into dozens of national product information updates, each with its own language, template, submission route and approval clock.
That fan-out is what makes labelling difficult. The content is agreed centrally, but it is implemented locally, under different national rules, by different teams, against different deadlines. Keeping track of which market holds which version, and why, is a genuine control problem.
Labelling is also unusually visible. It is read by prescribers and patients, it is checked at inspection, and it is one of the more common reasons a submission cycle gains an unplanned round of questions. Getting it right is not an administrative task — it is a control problem with a scientific core.
What we do
Five connected areas
Most providers cover part of this chain. The breaks between the parts are where the errors and delays live, so we work across all of it.
Core labelling documents
Development and maintenance of the company core data sheet and the core safety information within it, including derivation from the investigator's brochure for first-to-file products, and reference safety information used for clinical trial reporting.
Regional implementation
Translating agreed core content into each region's required format and structure — prescribing information, patient leaflets and packaging text — tracking where local requirements legitimately diverge from the core position, and documenting the justification when they do.
Structured and electronic labelling
Structured product labelling for the US, drug listing and establishment registration data, and preparation for electronic product information formats as those requirements develop in other regions.
Labelling review and control
Comparison of draft and approved labelling against the governing source across languages, version control across the document set, and a documented trail of what changed, when and on whose authority.
Labelling operations
Gap assessments across a portfolio, safety label change implementation and tracking, and label harmonisation following acquisitions, divestitures or entity changes.
Scope
The documents we work in
Labelling terminology varies by region and by company. This is the scope we mean when we say labelling.
| Document | Region | Reference | What it governs |
|---|---|---|---|
| Company core data sheet | Global | CCDS / CCSI | The company's own reference position on safety and product information, from which regional labels are derived. |
| Reference safety information | Global | RSI | The safety reference used to assess expectedness in clinical trial safety reporting. |
| Summary of product characteristics | EU | Annex I | Prescribing information for healthcare professionals, structured to the QRD template. |
| Labelling and package leaflet | EU | Annex IIIA / IIIB | The required text for immediate and outer packaging, and the patient-facing leaflet subject to readability testing. |
| Prescribing information | US | 21 CFR 201.56–57 | US prescribing information in Physician Labeling Rule format, including Highlights and Full Prescribing Information. |
| Medication guide | US | 21 CFR 208 | Patient labelling required for products with specific risk-communication obligations. |
| Structured product labelling | US | SPL | The XML representation of content of labelling used for FDA submission and drug listing. |
| Drug listing and NDC | US | 21 CFR 207 | Establishment registration and product listing data, including National Drug Code assignment. |
| Information supplied with the device | EU | MDR Annex I ch. III | Label content and instructions for use required to accompany a medical device. |
How we work
From an approved change to approved national text
Establish the source of truth
Confirm which document governs, what is currently approved in each market, and where the portfolio has already drifted from the core position. Most labelling problems start as an unanswered version question.
Assess the impact
Determine which markets and presentations a change touches, what submission route each requires, and which national deadlines apply. This is the step that determines the whole timeline.
Implement regionally
Produce the regional documents in required format and language, holding local deviations to those with a documented justification rather than those that accumulated by habit.
Review against source
Compare each national document against the governing text rather than against its own previous version. Machine comparison first, human review on what the comparison flags.
Submit and track to approval
File through the correct route in each market and track to national approval, so the status of a change is a fact in a system rather than an email thread.
Hand over and close out
Release approved text to your packaging and supply colleagues with the implementation date and version clearly identified, and close the change with evidence rather than assumption.
Where digital changes it
The most automatable work in regulatory affairs
Labelling is high-volume, highly repetitive, heavily multilingual and unforgiving of small errors. That combination is precisely where machine assistance is worth the validation effort it costs.
Comparison instead of re-reading. Automated comparison against the governing source finds differences far more reliably than a person reading two documents side by side for the ninth time in a day. Human judgment then goes where it belongs: on whether a flagged difference matters.
Component reuse instead of retyping. When approved statements are managed as reusable components rather than buried in documents, a core change propagates as a controlled update rather than as forty independent editing tasks.
Portfolio visibility instead of spreadsheets. Knowing which markets are on which version, and what is outstanding, should be a query — not a fortnight of manual reconciliation.
Outcomes
What good looks like
These are the outcomes we work towards and the measures we agree at the start of an engagement. They are objectives, not guarantees, and they depend on the state of your portfolio and data.
- A single, current answer to "what is approved where" that does not require a manual exercise to produce.
- Core-to-regional changes implemented on a predictable cycle, with national deviations that are justified rather than inherited.
- Every approved national text traceable to the core document version it came from, with the review evidence retained for inspection.
- Fewer avoidable questions from health authorities arising from labelling inconsistency.
- Approved text released to packaging colleagues with the implementation date identified, rather than discovered after it.
- Labelling capacity that scales with the portfolio instead of with headcount.
Related
Connected routes
Bring us the challenge
Bring us a labelling problem you have not been able to close.
A stalled harmonisation, a portfolio nobody can report on, a safety change with an implementation date approaching. Those are the conversations we are most useful in.