Pricing
Pricing per document, per axis, by page volume and, for scientific review, by reference count. Price shown before validation.
EryonOne
Use cases Pharma and ANSM
Review your promotional material before MLR and ANSM approval
EryonOne checks every claim against the SmPC, every figure against its source and every piece against the statements it must carry. For each point, it quotes the passage and the text at stake. Your team decides, before internal sign-off and the ANSM filing.
01 Checks
What EryonOne checks, point by point
Six checks drawn from the French Public Health Code, ANSM doctrine and your own rules, run on every piece.
Every claim against the SmPC
Indication, posology, population, contraindications, warnings: each sentence is matched against the SmPC and marketing authorisation you provide. A claim with no anchor is flagged, even when it is otherwise accurate.
Public Health Code R.5122-1, L.5122-2Every figure against its source
Percentage, comparison, endpoint: the figure is checked against the study it cites. Primary or secondary endpoint, population, confidence interval, follow-up.
Scientific axisObjectivity and proper use
Unproven superlatives, shortcuts on treatment duration, a surrogate endpoint presented as a clinical benefit: whatever overstates the product's properties is flagged.
Public Health Code L.5122-2Benefit / risk balance
Advertising must present benefits and risks in a balanced and consistent way. A missing or buried warning is flagged.
ANSM, Presentation of safety dataMandatory statements by audience
Healthcare professionals or the general public: the required statements differ. Missing ones are flagged, shortened formats included.
Public Health Code R.5122-8, R.5122-3Your own rules
Approved claims matrix, editorial charter, glossary: uploaded as requirements, they are checked in the same pass as the official texts.
Your internal requirements
02 Common gaps
The gaps we find most often
From one company to the next, the same gaps come back. They are rarely errors of substance: an accurate sentence that steps outside the frame, a statement lost along the way.
An accurate claim that is not in the SmPC
The figure comes from a sound publication, not from the SmPC. The claim steps outside the marketing authorisation, and the SmPC is what counts.
Public Health Code L.5122-2
A secondary endpoint presented as overall efficacy
“Effective in nearly 90% of patients”: the result concerns a secondary endpoint, an age band, one week of measurement. The sentence turns it into a general promise.
Public Health Code L.5122-2
A warning less visible than the benefit
The benefit in the headline, the warning in a footnote. ANSM expects a balanced and consistent presentation of benefits and risks.
ANSM, Presentation of safety data
A first-line position HAS does not support
The piece positions the product first line, while the treatment strategy recommended by the French National Authority for Health (HAS) places it later. The wording of the indication is not enough to settle it.
Public Health Code L.5122-2
A statement lost in the short format
Banner, e-mailing, shortened detail aid: the variant drops a mandatory statement, or its link to the public medicines database leads to another strength.
Public Health Code R.5122-8 and ANSM recommendation on mandatory statements
Right yesterday, wrong today
A variation changes the SmPC, a recommendation is updated: the sentence has not moved, its basis has. Every piece must remain justifiable against the version in force.
Consistency over time
03 How it works
A review, end to end
The piece, its references, a few minutes, then your call. The example shows a finding as it appears in the report.
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1You upload the piece and its references
The piece as a PDF, with the SmPC, the HAS opinion, the studies it cites and, if you have one, your claims matrix.
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2You choose the review axes
Regulatory, scientific, linguistic, formatting. The price shows before launch: nothing is charged without your approval.
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3EryonOne returns its findings
Within minutes. Each finding quotes the passage, the source and the requirement at stake, with, where available, a confidence score.
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4You decide
Accept or dismiss each finding: the decision is kept, and the report exports for your MLR committee.
04 Use cases
Use cases
Pharmaceutical companies preparing an internal review.
Healthcare agencies adapting content to the French market.
International teams wanting to structure marketing, medical and regulatory exchanges.
05 Limits
An assistant, not a regulatory authorisation
EryonOne is an assistant, not a validator. Business responsibility (regulatory, medical, quality, legal) stays with your teams. The report is working material, not an approval.
Frequently asked questions
Your questions about this use case
Does EryonOne deliver an ANSM approval?
No. The PM or GP visa is granted by ANSM, and internal sign-off stays with your teams. EryonOne prepares the review upstream: its report is working material, not an authorisation.
Which promotional materials can be reviewed?
For now, review is available on PDF. Word and PowerPoint come next. Detail aids, brochures, e-mailings, web pages, presentations, product sheets or scripts must therefore be provided as PDF.
Can the tool compare an asset with the SmPC or MA?
Yes, if the reference documents are provided: SmPC, marketing authorisation, HAS opinion, bibliography. Each gap quotes the passage of the piece and that of the reference.
Who makes the final decision?
Regulatory, medical or legal teams always keep the final say.
Can you review against our claims matrix?
Yes. Upload it as an internal requirement, with your charter or glossary: the findings that relate to it cite it, like an official text.
How much does a review cost?
The price depends on the number of pages, the axes you choose and, for the scientific axis, the number of references to check. It shows before every launch (pricing), and the first review of a new account is free, for a document of up to 10 pages.
Does my material stay confidential?
Yes. Documents are processed in France, in Roubaix, on a SecNumCloud-qualified OVHcloud offer, and are never used to train a model.