Catches the completeness failure that costs a review cycle
Dossiers are refused at validation for administrative reasons far more often than scientific ones. A section absent, a cross-reference pointing at a document that was renumbered, a study cited in the summary and missing from the annex, a signature page nobody scanned. Each costs a review cycle, and a review cycle is months.
This agent checks the mechanical half. It reads the required structure from your knowledge base — the guidance, the checklist, the template your team works to — and reports what is missing, what is present but empty, and where the dossier contradicts itself about its own contents.
It does not read science. It does not judge whether evidence supports a claim, whether a study design is adequate, or whether a submission is likely to be approved. Those are qualified judgements carrying legal weight, and they stay with the people who hold them. What it removes is the eleven-o'clock check before a filing deadline that nobody should be doing by hand.
The most expensive kind of avoidable delay there is.
Rather than at eleven at night before the deadline.
What was checked, against which guidance, and when.
The guidance and template your team works to, read from your knowledge base.
A citation pointing at a renumbered document is the failure nobody finds by reading.
A section that exists as a heading with a placeholder underneath fails validation like a missing one.
A study named in the summary and absent from the annex, versions that disagree, dates out of sequence.
No opinion on evidence, study design, or likelihood of approval. Those are qualified judgements with legal weight.
It produces a gap list. Filing is a regulated act by a named person.
Why Pharma & Life Sciences in particular. Submissions are refused on administrative grounds far more often than scientific ones, and every refusal costs a review cycle — months of a product's life.
Runs unattended
Started by you or by an event, and it finishes on its own. Nothing waits for someone to be at a desk.
The same standard every time
The two-hundredth item is held to the bar the first one was. Consistency is the part people cannot sustain.
It cannot act on its own
Regulatory Dossier Checker has no path to sending, spending or committing. That limit is why its output is safe to act on.
This agent runs server-side through the PROMIVO runtime. Each run is logged step by step and every tool call is permission-checked before it executes.
Read-only by design. This agent has no path to sending, spending, publishing or committing anything. Where that limit is the product, removing it would remove the reason to trust the output.
Demo dataIllustrative sample output, abridged.
{
"documents": [],
"jurisdiction": "EU",
"submissionType": "Module 2 summary set"
}{
"escalate": true,
"findings": [
{
"issue": "broken-reference",
"detail": "Cites study report CSR-2211 v2. The document list contains CSR-2211 v3 only; v2 is not in the dossier.",
"section": "2.7.4",
"requirement": "Every cited report must be present at the cited version.",
"sourceDocument": "Internal submission checklist v6 — item 14"
},
{
"issue": "empty",
"detail": "Section present as a heading with a placeholder beneath it.",
"section": "2.5",
"requirement": "All Module 2 summaries final before submission.",
"sourceDocument": "Internal submission checklist v6 — item 3"
}
],
"disclaimer": "A structural and consistency check against your loaded guidance. Not a regulatory opinion, not an assessment of any scientific content, and not a statement that this dossier is complete or approvable.",
"notChecked": [
"Scientific and clinical content. Nothing in this dossier was read for meaning, adequacy, or conclusion."
],
"guidanceFound": true,
"escalationReason": "A required summary is empty and one cross-reference cannot be resolved.",
"guidanceDocument": "Internal submission checklist v6"
}No integrations required.
Every required section and cross-reference verified.
Find the references that now point at the wrong version.
Establish what is actually in it before you commit to a date.
$449/month
Billed monthly through your PROMIVO subscription. Cancel at any time.
Runs consume your plan allowance for agent executions and tokens. See plan limits.
No, and it must not. Whether evidence supports a claim is a qualified assessment with legal and patient-safety consequences. This checks structure, presence and internal consistency only.
No. Nothing that reads a table of contents can tell you that, and anything claiming to should be treated with suspicion.
Whatever you load. Guidance is versioned and jurisdictional, and an agent quoting a remembered version would be quoting a wrong one.
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