FHIR ePI and artwork checks, without an ePI team
The EU's move to electronic product information adds a whole discipline most teams aren't staffed for. Regunaut handles the labelling work today, proof-checking artwork against approved text and the QRD template, and gives you a managed path to FHIR-based ePI as it becomes mandatory.
Artwork deviations become ePI-ready content
2 deviations
Outcome
Artwork right the first time, ePI-ready
Regunaut compares what is on the mockup with what was approved, then structures the clean result for electronic product information.
ePI is coming, and labelling is already a manual, error-prone grind
Proof-reading mockups against approved text and the QRD template, across PIL, SmPC, packaging and every CMS language, is slow and easy to get wrong. A single slip means rejected artwork. The shift to FHIR-based ePI then demands skills and tooling most lean teams don't have in-house.
Clean labelling now, ePI-ready next
Proof-check your mockups
Compare PIL, SmPC and packaging against the agency-approved text and the QRD template, in every language.
Fix deviations before submission
Get a clear pass/deviation report you can act on, so artwork reaches the agency right the first time.
Move toward ePI on a managed path
As FHIR-based ePI becomes mandatory, author and convert product information to the standard without building a team around it.
Catch labelling deviations and prepare ePI fields
Workbench explains what failed, what to fix and what can be structured for ePI.
Compare this EN PIL mockup against the approved text and QRD template. What must be fixed before submission, and what is ready for ePI?
Executive summary
The mockup is close enough to rescue, but not clean enough to submit. Submission should pause for two targeted labelling fixes, then move straight into ePI structuring.
Section 3 dosage wording diverges from the approved text, and the QRD heading is missing the required strength. Those are submission blockers, not cosmetic edits.
The good news: the remaining core fields are clean enough to map into the ePI data model. The team gets a proof-check result and a structured ePI starting point in the same pass.
Labelling readiness report
Each recommendation carries its reasoning and a source trail, so the result can go straight to RA, BD or the product owner.
Review notes
One hub, from proof-check to ePI
No team to stand up
Get specialist labelling and ePI capability without hiring or restructuring for it.
Right the first time
Catch deviations before submission and avoid reprints, rejected artwork and regulatory queries.
Ready for the transition
When ePI becomes mandatory, you're already set up to make the move.
Specialist labelling and ePI capability, minus the specialist headcount.
Get clean labelling today, and ePI when you need it
See how Regunaut handles proof-checking and the path to FHIR-based ePI.