Regulatory Dossier Checker
Catches the completeness failure that costs a review cycle
5 of 8 dossier sections need attention.
8 dossier sections checked. 5 flagged. The largest gap is 107 days.
Start with GMP certificate. Product A has the most flagged.
Whether the content satisfies the regulator is for a regulatory specialist, not this list.
Why rows were flagged
- Document expired40%
- Required section missing40%
- Present but not signed20%
Value flagged by Dossier
- Product A3
- Product B2
Items to act on, worst first
| Item | Dossier | Value | Days since expiry | Why |
|---|---|---|---|---|
| GMP certificate | Product A | 1 | 107 | Document expired |
| Import licence | Product B | 1 | 29 | Document expired |
| Stability data | Product A | 1 | 0 | Required section missing |
| Site master file | Product B | 1 | 0 | Required section missing |
| Labelling | Product A | 1 | 0 | Present but not signed |
What to do this week
- Resolve GMP certificate first: it is the most urgent on the list.
- Fix the data or the status on every flagged row, then re-run.
- Re-run this check every time the list changes, before it reaches a decision.
Do
- Fix the highest-risk item first, then run the check again on fresh data.
Don't
- Don't act on one row alone: open the source record first.
How to improve
- Add more detail per row (owner, date, source) so the next report can trace each item.
- Add a second period of data so the next report can show whether things are improving.
Demo
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
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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