Prepare material for medical, legal and regulatory review — claims read against the approved label, references checked against what they are cited for, expiry tracked — the reviewers who sign still decide.
Take the piece as submitted — its claims, its citations, its layout and the audience, market and indication it names.
02
Read the approved label in force, the reference pack and the piece's own history of versions and comments.
Reason
03
Match each claim to the reference cited for it, and read whether that reference says what the claim says.
04
Check the annotation — each citation tied to a page, table or figure a reviewer can open, not to a document alone.
05
Read the piece against the approved indication, the safety information it carries and the audience it is built for.
Decide
06
Surface where fair balance, prominence or the impression a reader is left with looks thin, and leave the call to a person.
07
Hold a claim whose source does not carry it, and name the line, the citation and the page it was checked against.
Out
08
Assemble the review package — the annotated piece, the sources opened, the open comments and the state of each.
09
Retain the label version read, the references opened, the reviewer comments and who closed each.
→Product statement
The agent reads, checks, annotates and assembles. Approval, certification, clearing a claim and closing a reviewer's comment stay with the medical, legal and regulatory reviewers who sign.
Example workflow
One piece, end to end
AgentHuman
1Piece submittedA new piece, a revision, a market adaptation or a re-certification falling due
2Label and sources loadedThe approved label in force, the reference pack, prior versions of this piece and the comments left on them
3Claims read against sourcesEach claim matched to the reference cited for it, and to the label statement it is said to rest on
4Presentation checkedAnnotation to the page, indication statement, the safety information the piece carries, audience, market and expiry
No human action required
Stages 1 to 4 run without a person in the loop — the source reading, the annotation check and the expiry check are finished before a reviewer opens the package.
5DecisionSplits on whether the cited source carries the claim
Claims reach their sources
Reaches the reviewers as an assembled package.
Source will not carry the claim
Held with the line and the page named.
Medical, legal and regulatory reviewers
Medical weighs the science and the balance, legal the risk, regulatory the fit to the label — each signs their own part, and the approval is theirs to give or refuse.
Open the pack · Comment · Send back
Signed off — handed back▼
6Review record written backThe state each reviewer left, the date the piece now carries and when it falls due again, where policy allows
7Outcome evaluatedClaim-to-source agreement, annotation misses, what reviewers added that the checks had not raised, by cohort
Reviewer comments
Every comment a reviewer writes that the checks had not raised is counted.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Approving a piece, or any part of it.
Signing a review or certifying material for use.
Clearing a claim as substantiated.
Deciding a piece is compliant or fairly balanced.
Automation boundaryAgent acts unaided
✓Read each claim against the label and its cited source.
✓Check each citation resolves to a page a reviewer can open.
✓Assemble the review package with the open comments and their state.
Write actions run only inside the approval boundaries agreed during implementation. Approving a piece is not one of them.
Closing or resolving a reviewer's comment.
Re-certifying material after a label change.
Releasing a piece to another audience or market.
Changing the reference pack or the check rules.
Example output
One claim on one piece, annotated
Everything the agent raises is attached to the line it was raised on and the source it was read against.
Review output · one piece, one claimIllustrative example
Piece
Claim under check
Label read
Claim status
Confidence
Annotation
HCP detail aid, revision
Onset earlier than comparator
Version in force
Held for medical
78%
Two citations lack a page
As receivedThe piece as submitted, the claim as written on it, and the label version the check was run against.
Evidence usedApproved label, datedCited reference, pagePrior version comments
Why it is heldA different endpoint in a different population, so the source does not carry this line.
ActionOpen the packCommentSend back
What the score decidesIt decides how closely a reviewer reads this claim, not whether the claim is substantiated.
Value
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value landsValue 01 – 04
Every piece in the queueNew, revised, adapted or falling due
03Label & references
Trace each claim to its source
Use the approved label in force, the reference pack behind each claim and the comments left on earlier versions of the piece.
01Approved path
Spend the meeting on judgement
The source reading, the annotation check and the version history are done before the meeting opens, so the hour goes on the arguable lines rather than on page numbers.
02Human review
Name the line and the page behind it
A claim whose source does not carry it is raised with the citation and the page it was read at, rather than argued from memory in the third review round.
04Build an evidence trail
Retain the label version read, the sources opened, the flags raised, every reviewer comment and who closed it — on both paths.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
The checking breaks on comparative and adapted pieces
A claim lands in this number when a reviewer re-sources, rewrites or strikes it after the checks passed it. Comparative lines are weighed against evidence rather than matched to it, and adaptations carry claims approved elsewhere.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Comparative and superlative claims
5.6%
3.6×
Review
Market adaptations of approved pieces
3.9%
2.5×
Review
Data-on-file and unpublished sources
2.8%
1.8×
Watch
Routine reprints, claims unchanged
1.1%
0.7×
Normal
Bar: re-sourced-claim lift vs. routine-reprint baseline · scale 0–4.0× · tick at the 2.0× threshold2 of 4 slices over threshold
Evidence-linked improvement
Reviewer comments are the measurement, not the noise
The comments worth counting are the quiet ones — a citation swapped without a word, a page number typed in by hand, a line struck with no reason given.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
One material cohort starts collecting comments the checks never raised.
02Diagnose
The comment is set beside the claim it was written on, and the source both read.
03Improve
Nothing enters the check until the person who owns that rule has signed it.
04Verify
The corrected pieces go through again, to see whether the check raises them now.
05Learn
A claim that had to be re-sourced is not checked from the old source again.
Learn → DetectThe return edge. A reviewer reads no less because of it — what changes is how much of the piece has already been traced by the time they start.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, label and references, claim and presentation checks, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Workflow discovery and automation-boundary definition.
02Approved-label and reference-pack mapping.
03Review-system and asset-store access review.
04Claim extraction from the piece as submitted.
05Claim-to-source reading and citation checks.
06Annotation checks down to page and figure.
07Indication and audience clearance checks.
08Fair-balance and safety-information flags.
09Expiry and re-certification tracking.
10Evaluation suite, slices and regression pieces.
11Package assembly and comment-state write-back.
12Observability, deployment and Agent Care handover.
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallelFinal scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
Capability✓ in scope · — not at this tierPilotOne product, one piece typeProductionProduction review integrationAdvancedSeveral products / markets
Introduced at Pilot
Claim-to-source reading✓✓✓
Approved-label and indication checks✓✓✓
Annotation checks to page and figure✓✓✓
Fair-balance and safety-information flags✓✓✓
Audience, market and expiry checks✓✓✓
Review package with the open comments✓✓✓
Reviewer gate on every piece✓✓✓
Baseline evaluation✓✓✓
Introduced at Production
Review-system and asset-store write-back—✓✓
Observability and evaluation—✓✓
Introduced at Advanced
Multi-market and multi-product controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on products and markets in scope, piece types, the state of the reference pack, review-system integrations, approval controls and deployment requirements.
Separate from buildBuild pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bringWe build with it
01The approved label each product is promoted against→Approved-label and indication checksWeek 1
02Your reference pack, and what each reference is cited for→Approved-label and reference-pack mappingWeek 1
03Access to your review system and asset stores→Review-system and asset-store access reviewWeek 2
04Pieces as they are really submitted, annotations and all→Claim extraction and claim-to-source readingWeek 2
05Your house rules on fair balance and safety information→Presentation flags and safety-information checksWeek 3
06Pieces your reviewers sent back, and the comment that did it→Evaluation suite, slices and regression piecesWeek 4
07Named medical, legal and regulatory reviewers→Package assembly, then supervised review cyclesWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Phases are drawn over the weeks they actually occupy. Week 5 carries both the last evaluation work and the first packages going to real reviewers.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Products, piece types and what the agent may not doW2Label in force, reference pack and the claim baselineW3Annotation, indication, audience and expiry checksW4Fair-balance flags, evaluation suite and material slicesW5Review-system integration and supervised packagesW6Reviewers work from the agent's packages, then Agent Care
Reading the bandWhere a bar stops, the work it names stops with it. Week 2 rebuilds a baseline from pieces your reviewers already commented on, so the later checks are scored against people rather than against a rulebook.
At the end of W6What your reviewers added that the checks never raised is counted and written down. That number is what Agent Care is held to afterwards.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build an MLR agent around the review your signatories already run.
Show us one product, a piece as it really reaches review, and the reference pack its claims are meant to rest on. Two kinds of comment come out of an MLR meeting: the ones a source could have settled before anyone sat down, and the ones that need a signatory's judgement. We build for the first kind only, and the second is where your reviewers should still be spending the hour.
