Carry the promises made to a regulator on one register — milestone, status word, market, the evidence behind a change — then hold it for the named regulatory lead, who decides what is filed.
A commitment is agreed, and it enters the register with its milestone, its market and the letter it came from.
02
An anniversary falls, and the status pack for that application is built against the window at 21 CFR 314.81(b)(2).
Reason
03
An alternate date is agreed with a review division, and the register carries it beside the approval anniversary.
04
An accelerated approval enters, and its progress cycle under 21 U.S.C. 356b(a) is counted apart from the annual one.
05
A status word is put up from the set the regulation defines, with the schedule it was read against attached.
Decide
06
A change is raised, and the supporting data, the tiers in play and the written reason are gathered market by market.
07
A variation is drafted, and the register stores which Guidelines governed it: the 2013 set, or C/2025/5045.
Out
08
A conditional EU authorisation renews, and the date the application is due before expiry is counted, not the expiry.
09
A write action runs only inside the approval boundaries agreed during implementation.
→Product statement
The agent assembles the register; a named regulatory affairs lead classifies, decides what is filed and signs — and the exposure that follows is the company's, not that person's.
Example workflow
One commitment, letter to filing
AgentHuman
1Commitment receivedApproval letter, variation record, inspection response or register export
2Register assembledMilestones, markets, status words and open evidence, each with its named source
3Change pack draftedMilestone view, classification evidence, open items and confidence
4Controls appliedMilestone arithmetic, completeness tests per configured market, guideline-date checks and confidence threshold
No human action required
Stages 1 to 4 run unaided, and nothing is filed at any of them — the agent is assembling evidence, and the regulatory lead's lane opens at the confidence gate.
5DecisionBranches at the confidence threshold
High confidence
Goes to the regulatory lead.
Low confidence
Adds a CMC or labelling read first.
Regulatory lead
The pack is held with its source records, its open items and the confidence.
Approve · Amend · Send to regulatory review
Approved — released to file▼
6Commitment register updatedOnly where write access and approval policy allow it
7Outcome evaluatedAmendment distance, open-item outcomes, agency correspondence and post-filing corrections
Amendments
Each amendment the regulatory lead makes is counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Classifying a change into a reporting category.
Determining reportability in any market.
Filing a supplement, a variation or a status report.
Choosing the status word an annual report states.
Automation boundaryAgent acts unaided
✓Assemble the register from approval letters, variations and inspection responses.
✓Compute each milestone and window from the dates already on file.
✓Gather the supporting data behind a proposed change, market by market.
✓Name what is missing or divergent, and hold the pack for the lead.
Writes run only inside the boundaries agreed at implementation, and never ahead of a filing.
Assessing the effects of a change before distribution.
Agreeing a new milestone date with a review division.
Proposing established conditions, where a region takes them.
Changes to milestone, market or approval rules.
Example output
One commitment, annotated
Everything the agent assembles is attached to the record it was drawn from.
Commitment register output · single applicationIllustrative example
Application
Commitment
Time to milestone
Source of record
Confidence
Owner of record
BLA, accelerated approval
Confirmatory-trial milestone stated in the approval letter
214 days
Approval letter on file
86%
Regulatory lead, named on the register
As receivedTaken from the approval letter and the register on file — nothing on this side is written by the agent.
Source facts usedApproval letter, datedPrior status reportStudy milestone plan
Why this is openThe status word is the lead's to choose — 21 CFR 314.81(b)(2)(vii).
ActionApproveAmendSend to regulatory review
What the score decidesBelow the configured threshold the item picks up a CMC or labelling read before the lead sees it.
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 applicationFrom the approval letter
03Assembly
Read the promise against its milestone
Established conditions are carried per market: the EU note of 4 March 2020 and MAPP 5018.3 of 29 November 2024 do not agree.
01Approved path
Commitments outlive the team
A change filed in the wrong category is product distributed without the approval the regulation required, and the unwind reaches the batches released, the markets moved on the same reasoning, and the next inspection.
02Human review
The sequence, and the promise
The submission helper asks whether a filing is structurally right for its region; this register asks whether every promise made to a regulator is tracked, evidenced and answerable.
04Build an evidence trail
The commitment, the milestone it carries and the lead who filed stay on the register.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Regulatory informationVeeva Vault RIM ArisGlobal · Ennov RIM
Agency sourcesFDA approval letters EMA · national registers
Quality systemsChange control · CAPA Veeva QualityDocs
Agent
Commitment register
Reads the record Assembles the pack Holds for the lead
Publishing and archiveeCTD publishing · archive Document management
A portfolio-level milestone-currency figure can read as healthy while a few markets and change types carry most of the returned items. Nestack reports the return rate by slice, not only in total.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Partner and licensed markets
7.2%
3.6×
Review
Conditional EU authorisations
5.3%
2.6×
Review
Cross-region CMC changes
3.6%
1.8×
Watch
Single-market annual-report changes
2.3%
1.1×
Normal
Bar: return-rate lift vs. single-market baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
A cycle is not done until a test exists
A cycle closes when the missed milestone is a regression case. That suite is what the next status report built is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Return rate rises for one market.
02Diagnose
The milestone agreed by people who have all since left is read back until the cause narrows to one.
03Improve
The change goes out with a number, and the commitments behind it travel with it.
04Verify
Nothing files while one touched commitment case is still red.
05Learn
It is kept for good, and the milestone rules are amended in the same commit.
Learn → DetectThe return edge. The next detection is measured against a longer suite than this one.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, register workflow, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Commitment workflow discovery and boundary mapping.
02Regulatory and quality-source assessment.
03Milestone, market and classification-rule mapping.
04Register ingestion and reconciliation.
05Pack assembly and source binding.
06Confidence scoring and exception routing.
07Regulatory-lead review workflow.
08Regulatory and quality-system integration.
09Milestone and classification cases.
10Guardrails and filing controls.
11Commitment-trail instrumentation.
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.
Capability✓ in scope · — not at this tierPilotOne product, one marketProductionProduction regulatory systemsAdvancedMultiple markets / products
Introduced at Pilot
Commitment register and milestones✓✓✓
Regulatory-lead approval✓✓✓
Milestone-currency baseline✓✓✓
Introduced at Production
Reporting by market—✓✓
Exception workflow in your systems—✓✓
Approved write-back—✓✓
Regulatory-system integration—✓✓
Introduced at Advanced
Multi-region guideline rules——✓
Multi-stage regulatory approvals——✓
High application count——✓
Multi-market variation controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, application count, 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
01Your approval letters and commitment list→Milestone, market and classification-rule mappingWeek 1
02Representative prior status reports→Register ingestion, reconciliation and the assembly baselineWeek 2
03Your variation history and change-control records→Commitment-register mapping and automation-boundary definitionWeek 1
04Access to relevant APIs, feeds or exports→Regulatory and quality-system assessment, then integration setupWeek 2
05Registers you would not want reconciled→Milestone cases and failure-mode testingWeek 4
06What no status report may leave open→Confidence scoring, item routing, guardrails and filing controlsWeek 3
07Named regulatory leads to review the pack→Regulatory-lead review workflow, then pilot and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Bands are measured against weeks actually worked, and that measurement puts two into week five.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Commitment workflow discovery, rule mapping and the automation boundaryW2Register integration and the reconciliation baselineW3Assembly workflow, milestone logic and review controlsW4Evaluation suite, milestone checks and failure-mode testingW5Quality-system integration, a pilot product and targeted correctionsW6One anniversary cycle run under the regulatory lead, then Agent Care handover
Reading the bandA bar covers only the weeks its own work is named in. The week 5 overlap is real, not padding.
At the end of W6When the status report validates, Agent Care takes the agent on.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build the commitment register before the next anniversary falls.
Show us your approval letters, your variation history and the lead who signs. Next step is a working session on one product: we put every commitment on one register with its milestone, its market and the evidence behind it, then show you what the pack hands your lead at the anniversary — with the classification left empty, because that determination is theirs and the exposure behind it is the company's.
