Regulatory Dossier Checker
Catches the completeness failure that costs a review cycle
- 8hard rules
- Things it must never do, enforced in every run
- 5handover rules
- Conditions where it stops and gives the work to a person
- 8output fields
- A structured result, not a paragraph you have to re-read
- ≤6steps per run
- Bounded work: at most 5 tool calls, enforced by the runtime
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.
Overview
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.
Benefits
No cycle lost to a missing page
The most expensive kind of avoidable delay there is.
The mechanical check, done properly
Rather than at eleven at night before the deadline.
A traceable record
What was checked, against which guidance, and when.
What it does
Checks against your own required structure
The guidance and template your team works to, read from your knowledge base.
Follows every cross-reference
A citation pointing at a renumbered document is the failure nobody finds by reading.
Present but empty is a finding
A section that exists as a heading with a placeholder underneath fails validation like a missing one.
Checks the dossier against itself
A study named in the summary and absent from the annex, versions that disagree, dates out of sequence.
Never reads the science
No opinion on evidence, study design, or likelihood of approval. Those are qualified judgements with legal weight.
Submits nothing
It produces a gap list. Filing is a regulated act by a named person.
What this changes
What this changes about your week
- It takes over
- The completeness and cross-reference check before a filing.
- Done today by
- Regulatory affairs, at eleven at night before the deadline.
- How often
- Every submission and every document update.
- Typical manual effort
- Checking a dossier's references by hand is days, and it is done under time pressure.
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.
How it runs
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.
- 1InputValidated against the agent input schema
- 2Modelclaude-opus-5 with automatic fallback
- 3Toolssearch_knowledge, extract_structured_data
- 4PermissionsRuns READ actions automatically; anything higher waits for approval
- 5OutputStructured result matching the output schema
- 6LoggingTokens, duration and every step recorded
Demo
Demo dataIllustrative sample output, abridged.
Input
{
"documents": [],
"jurisdiction": "EU",
"submissionType": "Module 2 summary set"
}Output
{
"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"
}Requirements
Integrations
No integrations required.
Before you start
- The dossier's structure and document list
- A knowledge base holding the applicable guidance or checklist
- Requires the All-Access plan or higher
Use cases
Before filing
Every required section and cross-reference verified.
After a document update
Find the references that now point at the wrong version.
Inheriting a dossier
Establish what is actually in it before you commit to a date.
Pricing
All-Access
Billed monthly through your PROMIVO subscription. Cancel at any time.
Runs consume your plan allowance for agent executions and tokens. See plan limits
FAQ
Does it assess our data?
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.
Will it say whether we will be approved?
No. Nothing that reads a table of contents can tell you that, and anything claiming to should be treated with suspicion.
Which guidance does it use?
Whatever you load. Guidance is versioned and jurisdictional, and an agent quoting a remembered version would be quoting a wrong one.
Reviews
Reviews open once customers have run this agent.
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