Place each document where the region's structure puts it, validate the sequence against the criteria in force, and show what the content plan still lacks — your regulatory affairs lead decides what is filed.
Take the content plan, the source documents and the sequence history of the application being built.
02
Read the module structure, the granularity and the validation criteria version that region and procedure use.
Reason
03
Place each document at the node its plan entry gives it, at the granularity agreed for that region.
04
Set the lifecycle operation — new, replace, append or delete — against the leaf in the history it acts on.
05
Resolve cross-references and hyperlinks to the document version current in this sequence.
Decide
06
Run the technical validation and hold the sequence on the leaves that fail it.
07
Route placement, granularity and requirement questions to the regulatory affairs lead.
Out
08
Present the candidate sequence, its validation report, and what the content plan still shows open.
09
Retain the placement, the operation, the version referenced and every change a publisher makes.
→Product statement
The agent assembles and validates inside the approval boundaries agreed during implementation. Filing, signature, the answer to a regulator, whether a requirement applies and the date stay with the regulatory affairs lead and the named signatory; the sponsor is accountable for what is filed.
Example workflow
One sequence, end to end
AgentHuman
1Sequence openedA planned submission, a variation or a question a health authority has already asked
2Scope resolvedRegion, procedure, application, the sequences already filed and the criteria version in force
3Documents placedEach document to a module node, at the granularity that region and procedure use
4Controls appliedLifecycle operations, cross-reference and hyperlink checks, technical validation and confidence threshold
No human action required
Stages 1 to 4 run without a person in the loop — the sequence is a candidate on disk until validation has run against it, so the lane stays empty until then.
5DecisionSplits on the validation result and the confidence threshold
Validation clean
Goes to the publisher as a candidate.
Failure or open question
Held with the leaf that failed.
Regulatory affairs review
The sequence is held with its validation report, the leaves that failed and the questions the agent could not settle.
Accept · Re-place · Return to RA
Accepted — handed back▼
6Candidate sequence handed overWritten to the publishing system only where access and approval policy allow; nothing goes to a regulator
7Outcome evaluatedValidation failures, re-placements, lifecycle breaks and what the review afterwards asked about
Re-placements
Leaves a publisher moves or re-operates are counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Sending a sequence to a regulator.
Signing or approving a submission or a document in it.
Answering a health authority on the company's behalf.
Deciding that a requirement does not apply.
Automation boundaryAgent acts unaided
✓Place documents against the plan entry and the region's structure.
✓Set lifecycle operations from the sequence history and resolve cross-references.
✓Run the technical validation and list the leaves that fail it.
✓Show what the content plan still has open.
Write actions run only inside the approval boundaries agreed during implementation. Filing is never one of them.
Committing the company to a submission date.
Agreeing structure or granularity for a new region.
Withdrawing or deleting a leaf already filed.
Changing validation profiles, templates or the content plan.
Example output
One document in a sequence, annotated
Everything the agent places is attached to the plan entry and the history it was read from.
Placement output · single leafIllustrative example
Document
Sequence
Operation
Placement
Confidence
Held for
Process validation report
Variation, one region
Replace
Module 3 · 3.2.P.3.5
93%
A superseded cross-reference
As receivedThe change request and the plan entry that asked for it — nothing on this side is decided by the agent.
Evidence usedContent plan entryRegion structure rulesSequence history
Why it stops hereThe report cites a leaf an earlier sequence replaced, so the link points at old content.
ActionAcceptRe-placeReturn to RA
What the score decidesBelow the configured threshold the placement is held for the RA lead instead of the publisher.
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 document in the planFrom the content plan and the change request
03Placement
Apply the region's structure
Use the module structure, granularity and validation criteria that region and procedure actually run.
01Approved path
Build from the plan entry
Each document is placed against the plan entry that asked for it and the leaf in the history it supersedes.
02Human review
Send what will not resolve
Failed validation, cross-references to superseded leaves and requirement questions reach the RA lead as a list, not as a sequence to re-read.
04Build an evidence trail
Retain the plan entry, the placement, the operation, the version referenced, the validation result and the publisher's correction — on both paths.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Regulatory information managementVeeva Vault RIM · Ennov · Lorenz ArisGlobal LifeSphere · Extedo
Three things move this number: what the dossier was built from before this sequence, whether that region has seen the application at all, and how many procedures one sequence is carrying. The rate counts re-placed leaves.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Migrated legacy dossiers
4.6%
2.9×
Review
First filing in a region
3.5%
2.2×
Review
Grouped and worksharing variations
2.6%
1.6×
Watch
Routine single-region variations
1.3%
0.8×
Normal
Bar: re-placed-leaf lift vs. routine-variation baseline · scale 0–4.0× · tick at the 2.0× threshold2 of 4 slices over threshold
Evidence-linked improvement
Corrections belong in the profile, not in one sequence
A publisher's correction is worth little while it stays in the sequence it was made in. What moves is the placement map, the profile or the rule behind it.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Re-placements or validation failures gather in one kind of sequence.
02Diagnose
Nothing is re-placed until we know whether the plan entry or the history it read was wrong.
03Improve
A named approver signs the change to the map or the profile before it is used.
04Verify
Affected sequences are rebuilt and revalidated on the current criteria.
05Learn
The plan entry carries the correction, so the next build starts from it.
Learn → DetectThe return edge. Nothing here shortens a clock the company is already answering to — it changes what the next sequence is assembled from.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, structure and sources, placement and lifecycle, validation and evaluation, publishing integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Workflow discovery and boundary definition.
02Region, procedure and content-plan mapping.
03Module structure and granularity rules.
04Document repository and RIM access review.
05Placement and document metadata extraction.
06Lifecycle operations against sequence history.
07Cross-reference and hyperlink resolution.
08Validation profiles and criteria versions.
09Regulatory affairs review and handover workflow.
10Evaluation suite and regression sequences.
11Publishing-system integration and observability.
12Deployment, documentation 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. No tier lets the agent file, sign or answer a regulator.
Capability✓ in scope · — not at this tierPilotOne region, one sequenceProductionProduction publishing integrationAdvancedSeveral regions and procedures
Introduced at Pilot
Placement against your content plan✓✓✓
Lifecycle operations set from history✓✓✓
Cross-reference and version checks✓✓✓
Technical validation before handover✓✓✓
Regulatory affairs approval✓✓✓
Baseline evaluation✓✓✓
Introduced at Production
Publishing-system and RIM integration—✓✓
Approved write actions—✓✓
Observability and evaluation—✓✓
Introduced at Advanced
Multi-region content plans——✓
Grouped and parallel procedures——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on the regions and procedures in scope, source repositories, publishing and RIM integrations, sequence volume, 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 content plan and who owns each entry in it→Region, procedure and content-plan mappingWeek 1
02The regions and procedures this dossier goes to→Module structure and granularity rules per regionWeek 2
03Access to your document repository and RIM→Document repository and RIM access reviewWeek 2
04The sequences already filed for the applications in scope→Lifecycle operations against sequence historyWeek 3
05The validation criteria versions each region runs→Validation profiles and criteria versionsWeek 4
06Sequences that failed validation or had to be re-published→Evaluation suite, regression sequences and failure-mode testingWeek 4
07Named regulatory affairs reviewers and publishers→Review and handover workflow, then pilot sequencesWeeks 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 cohort slices and the first sequences a publisher works from.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Boundary, regions in scope and the content plan agreedW2Repository and RIM access, module structure and granularityW3Placement, lifecycle operations and cross-reference resolutionW4Validation profiles, evaluation suite and failure-mode testingW5Publishing integration, first candidate sequences and correctionsW6Production validation on live sequences, then Agent Care handover
Reading the bandA bar stops where its work stops, and the gaps are not slack. Week 4 owns the validation profile: a region can hold a version in force that your tooling has not caught up with.
At the end of W6Your publisher takes a candidate sequence straight into the publishing system. Profiles and criteria versions move under Agent Care from that point.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build a submission helper around the dossier you already maintain.
Show us one application, the sequences already filed against it and the regions it goes to next. Most of the work in the first fortnight is not placement at all; it is proving that the dossier's own history can still be read back, sequence by sequence.
