Biotechnology AI agent · Promotional review

Promotional-Content Review (MLR) AI Agent

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.

Typical delivery: 4–6 weeks
Deployment: Your stack
MLR approval: Reviewers sign
After launch: Agent Care

What this agent does

Checks the piece before the reviewers do

01
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

Agent

Human

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 required

8 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 boundary
Agent acts unaided
- ✓Read each claim against the label and its cited source.
- ✓Check each citation resolves to a page a reviewer can open.
- ✓Flag thin fair balance, missing safety information, wrong audience and expiry.
- ✓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 claim

Illustrative example

Piece: HCP detail aid, revision
Claim under check: Onset earlier than comparator
Label read: Version in force
Claim status: Held for medical
Confidence: 78%
Annotation: Two citations lack a page

As received

The piece as submitted, the claim as written on it, and the label version the check was run against.

Evidence used

Approved label, dated
Cited reference, page
Prior version comments

Why it is held

A different endpoint in a different population, so the source does not carry this line.

What the score decides

It decides how closely a reviewer reads this claim, not whether the claim is substantiated.

Action

Open the packCommentSend back

Value

Where AI adds value

The same four claims, placed at the point in the workflow where each one applies.

Where the value lands

Value 01 – 04

Every piece in the queue

New, 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.

Build 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.

Promotional review
- Veeva Vault PromoMats
- Aprimo
- Ziflow
- Review and approval queues
Label & regulatory source
- Approved label and SmPC
- Core data sheet
- Regulatory information management
Reference pack
- Reference library
- Data on file
- Publications
- Literature sources

Agent

Promotional-content review

Reads label and sources
Checks claim to source
Assembles the package

Assets & distribution
- Digital asset stores
- Approved email
- Field content
- Web and social channels
Observability & evaluation
- OpenTelemetry
- Langfuse
- Supported monitoring/evaluation sources

Integration availability depends on the client's existing systems and API access.

Agent controls

Six layers between the model and the signature

Each control wraps the one inside it. A piece clears every layer before the package is assembled, and the signature sits outside all six.

L6 · Outermost — last line of defence

Inward → L1 · closest to the model

L6Rollback / safe modeReturn checking to the review team if evaluations or production signals degrade.Roll back

L5TraceabilityRecord the label version, the sources opened, the flags raised and every reviewer comment.Record

L4Reviewer gateApproval, certification and the closing of a comment stay with the people who sign them.Gate

L3Annotation stateA citation with no page, table or figure behind it is marked unannotated rather than supported.Mark

L2Label and audienceIndication, safety information and audience are read against the label version in force.Check

L1Source bindingClaims are read against the reference cited for them; what a source does not carry is raised, not reworded.Bind

Model coreCheck result proposed — claim read against source, annotation state, presentation flags and confidence

L1 – L2: Test whether a claim's source carries it
L3: Marks what no one can open at the line
L4 – L5: Keep the signature with the reviewers
L6: Pulls automation back when signals degrade

How Nestack evaluates it

Evaluate the checking, not only the package that comes out.

Coverage runs the whole depth of the workflow, and every layer is cut by slice.

Surface — the review package a reviewer opens

E1Claim-to-source evaluationDoes the cited reference say what the claim on the piece says?
E2Label-consistency evaluationDoes the piece stay inside the indication and the approved label?
E3Annotation evaluationIs each citation tied to a page a reviewer can actually open?
E4Presentation recallWere missing safety information and thin balance raised for a person?
E5Slice evaluationHow does check quality change across specific material cohorts?
E6Business outcomeWhat did reviewers add that the checks missed, and what came back?

Floor — the material that is in the field afterwards

Failure modes

Where each failure originates in the agent

Seven failure modes plotted against the five stages of the agent lifecycle.

Agent lifecycle

Direction of processing →

01 · Label & references
1 mode
- ML-01
  Superseded label version read
  A safety change landed after the pack was built.
Stage gathers
The label in force, the reference pack and prior versions
02 · Claim checking
1 mode
- ML-02
  Reference does not say it
  Different endpoint, different population, same citation.
Stage reads
Each claim against the source cited for it
03 · Presentation
2 modes
- ML-03
  Annotated to the file, not the page
  A reviewer cannot get from the claim to the line.
- ML-04
  Thin fair balance read as adequate
  Risk text is present, and nowhere near the benefit.
Stage checks
Annotation, indication, safety information and audience
04 · Package / release
2 modes
- ML-05
  Approved elsewhere, packaged here
  Another market's audience and indication, reused.
- ML-06
  Expiry passed while it waited
  Certification lapsed between submission and use.
Stage returns
The package the reviewers open and its open comments
05 · Change / Version
1 mode
- ML-07
  Silent check-rule regression
  A rule change stops a class of claim being read.
Stage tracks
Model, prompt, rule and reference-pack changes

Sev-1 · material may go out as it should not
Sev-2 · the claim cannot be checked as written
Sev-3 · the check degrades, reviewers carry it

See the complete Biotechnology failure-mode catalogue

Affected slices

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 aggregate

Illustrative example

Slice	Failure rate	Lift	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× threshold

2 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 stages

Switchback — the path turns at Improve and returns at Learn

01
Detect
One material cohort starts collecting comments the checks never raised.
02
Diagnose
The comment is set beside the claim it was written on, and the source both read.
03
Improve
Nothing enters the check until the person who owns that rule has signed it.
04
Verify
The corrected pieces go through again, to see whether the check raises them now.
05
Learn
A claim that had to be re-sourced is not checked from the old source again.
Learn → Detect
The 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.

Workstream

Week 1Week 2Week 3Week 4Week 5Week 6

01Workflow discovery and automation-boundary definition.Week 1
02Approved-label and reference-pack mapping.Week 1, Week 2
03Review-system and asset-store access review.Week 1, Week 2
04Claim extraction from the piece as submitted.Week 2
05Claim-to-source reading and citation checks.Week 2, Week 3
06Annotation checks down to page and figure.Week 3
07Indication and audience clearance checks.Week 3, Week 4
08Fair-balance and safety-information flags.Week 4
09Expiry and re-certification tracking.Week 4, Week 5
10Evaluation suite, slices and regression pieces.Week 4, Week 5
11Package assembly and comment-state write-back.Week 5, Week 6
12Observability, deployment and Agent Care handover.Week 6

12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallel

Final 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 tier	PilotOne product, one piece type	ProductionProduction review integration	AdvancedSeveral 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 price	From $5,000	From $8,000	Custom quote

Final build price: Confirmed 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 build: Build 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 bring

We build with it

01The approved label each product is promoted against
→
Approved-label and indication checks
Week 1
02Your reference pack, and what each reference is cited for
→
Approved-label and reference-pack mapping
Week 1
03Access to your review system and asset stores
→
Review-system and asset-store access review
Week 2
04Pieces as they are really submitted, annotations and all
→
Claim extraction and claim-to-source reading
Week 2
05Your house rules on fair balance and safety information
→
Presentation flags and safety-information checks
Week 3
06Pieces your reviewers sent back, and the comment that did it
→
Evaluation suite, slices and regression pieces
Week 4
07Named medical, legal and regulatory reviewers
→
Package assembly, then supervised review cycles
Weeks 5–6

Nothing else is required

Deployment, 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.

Phase

DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6

Week focus

W1Products, piece types and what the agent may not do

W2Label in force, reference pack and the claim baseline

W3Annotation, indication, audience and expiry checks

W4Fair-balance flags, evaluation suite and material slices

W5Review-system integration and supervised packages

W6Reviewers work from the agent's packages, then Agent Care

Reading the band: Where 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 W6: What your reviewers added that the checks never raised is counted and written down. That number is what Agent Care is held to afterwards.
Duration: Six-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.

Typical delivery: 4–6 weeks
Deployment: Your promotional review stack
MLR approval: Reviewers sign, always
After launch: Agent Care available

Nestack Agents · Promotional-content review (MLR)

AGT-BT-11 · Agent Care available after launch

Promotional-Content Review (MLR) AI Agent

Trace each claim to its source

Spend the meeting on judgement

Name the line and the page behind it

Promotional review

Label & regulatory source

Reference pack

Promotional-content review

Assets & distribution

Observability & evaluation

Superseded label version read

Reference does not say it

Annotated to the file, not the page

Thin fair balance read as adequate

Approved elsewhere, packaged here

Expiry passed while it waited

Silent check-rule regression

Detect

Diagnose

Improve

Verify

Learn

Build an MLR agent around the review your signatories already run.