Post-marketing commitment tracking that catches the promises made outside approval letters
Every promise to an authority on one timeline, owners alerted 90 days ahead.
See one case, screen by screen ↓Keeping every postmarketing requirement and commitment, EU obligation and local approval condition on record with its dates, owners and status until the agency confirms it is fulfilled. Post-Marketing Commitment Tracking does it with agents that read every approval letter, set of minutes and question response and put each item on one timeline by product, with the agency's exact words and the page.
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After approval, a sponsor owes its regulators a long list of things: studies required under 505(o)(3), paediatric studies deferred under PREA, clinical and CMC commitments, 180-day progress reports on an accelerated-approval confirmatory trial, EU specific obligations, Annex II conditions and post-authorisation measures, local approval conditions in Japan, Switzerland, Brazil or Australia. Each sits in a different letter with its own dates. Approval letters get entered into the tracker by hand; minutes and question responses are filed as correspondence.
The promises inside those minutes are entered only if someone notices them. In a Type C meeting the action items list FDA's tasks; the sponsor's dated promise sits three paragraphs up, in the discussion. Internal milestones — lots made, patients enrolled — are missed months before the agency date, and nobody sees it until regulatory operations compiles the annual status table and a commitment goes in as Delayed.
Estimated per application, by hand and with the status table drafted from the register — the working solution's own estimate before deployment.
Specialist agents read every letter and minute, catch untracked promises, watch the dates and draft the reports; the regulatory lead signs.
Northwind Bio has four marketed products — Veltrimab, Corventa, Talmirex and Nexarin, inherited from Halden Therapeutics — and 29 open items with 8 health authorities. On October 7, three new FDA letters are waiting. Here is what happens next, screen by screen, in the working solution.
Omar's home screen is a timeline by product: requirements as circles, commitments and promises as squares, coloured at risk, watch, on track or later. He clicks the red one on Veltrimab. PMC 4512-6, re-evaluate the HMW species limits, is due Oct 31 — 24 days away — and only 21 of the 30 commercial lots have been made. The panel shows where the date comes from: the approval letter for BLA 761412, page 2, in FDA's own words.
“Every date links to the page it came from.”
The Correspondence Reader classifies the S-008 supplement approval for Veltrimab, the fulfilment letter for Corventa PMR 3990-1 and the Type B minutes for Corventa. The Commitment Extractor finds 6 items with their page and exact words and sets a standing reminder aside. The Change & Duplicate Checker sorts them: 4 new, 1 change to CMT-101, PMR 3990-1 fulfilled.
“Proposed dates are on the timeline, dashed. Nothing is final until you sign.”
The S-008 approval for Crohn's disease brings PMR 4512-7, a PREA study in patients 6 to 17 years old: final protocol 06/2027, study completion 06/2030, final report 12/2030. It lands on Veltrimab's lane as a dashed, proposed date, owners Omar Haddad and Dr. Maya Chen. On Corventa, two promises from the Type B minutes appear the same way: a revised SAP for CRV-402 by Dec 15, and a paediatric formulation bridging plan with the next annual report.
“Proposed · waiting for your signature”
A new Veltrimab approval makes the Promise Finder re-read the product's 63 minutes and responses on file, discussion included. The panel lists the 5 promises it finds in minutes and responses: two Health Canada responses already on the timeline as CMT-111 and CMT-308, the two new Corventa promises — and one from a Type C meeting that was never tracked.
“Never tracked · filed Jun 19”
In the Type C minutes for the Veltrimab prefilled syringe, the sponsor's promise sits in the discussion of Question 3, not in the action items. The minutes were filed in June with no timeline entry. Omar sees the exact sentence, the page, the date highlighted and the proposed owners: himself and Lena Ortiz, the CMC owner.
“The sponsor agreed to submit a shipping validation report for the 200 mg/mL prefilled syringe … to the BLA by March 31, 2027.”
“Add to the timeline” opens the promise with its due date fixed by the minutes, the functional owner — Lena Ortiz — and the meaning of the signature: “I approve this timeline entry”. The alerts are already scheduled and the minutes stay linked as the source. The Promise Finder only proposes; nothing reaches the timeline without his signature.
“Alerts are scheduled at 90, 60, 30 and 7 days before Mar 31, 2027.”
The promise becomes CMT-116, a solid square on Veltrimab's lane, Pending, with the Type C minutes as its source. The count of open items goes from 29 to 30. Lena Ortiz is notified as owner, and the signature is on the activity trail.
“CMT-116 is on the timeline · Lena Ortiz notified · alerts set”
The letter opens beside what the agents found, each with its page and confidence: PMR 4512-7 at 97%, the change to the long-term remission registry at 94% with the old and new wording side by side, and PMC 4512-8 for a drug-tolerant ADA assay. The distribution reporting reminder is set aside as not a commitment. Omar decides each item and signs; the change to CMT-101 also goes to Dana Okafor in compliance for countersignature.
“A change to an existing commitment also goes to Dana Okafor (compliance) for countersignature. The original wording stays in the record history.”
On CMT-106 the Deadline Monitor has raised a slip: 25 lots released was planned for Jun 30, 30 lots for Aug 31, the data review for Sep 30 — all missed. The 30th lot is planned for Feb 2027, so Oct 31 cannot be met. “Request a new date” drafts the reason in the agency's terms; the new date needs Omar's signature and Dana Okafor's countersignature.
“Internal targets from the owner's plan are shown with the agency date — they slip first.”
Veltrimab's BLA 761412 reaches its approval anniversary on Oct 21, so its status report under 21 CFR 601.70 is due Dec 20. The Status Reporter writes one row for each of the 6 requirements and commitments — original and current schedule, the agency status category and an explanation with its evidence. PMC 4512-6 goes in as Delayed. Sam Patel reviews; Omar signs.
“Every status uses the agency's words; every explanation cites its evidence.”
The same commitments, seen by the five people who carry them — what their year looked like, and what it looks like now.
Specialist agents read every letter and minute, catch untracked promises, watch the dates and draft the reports; the regulatory lead signs.
Reads every incoming letter, set of minutes and response; works out the agency, document type, product, application and date. Translated copies keep a link to the original.
Finds every requirement, commitment, condition and promise — PMRs and PMCs, specific obligations, Annex II conditions, post-authorisation measures, local conditions — with the exact wording, the page, the legal basis and every date. Standing reminders are marked as not a commitment.
Reads meeting minutes, question responses and emails for what the company said it would do — in the discussion as well as the action items — and checks each against the timeline. When a product receives a new approval, it re-reads that product's minutes and responses on file.
Matches each found item against the register by number, product, wording and study: new, a change to an existing record, or a status event such as fulfilled or released. Links the same study across markets.
Proposes the regulatory owner and the functional owner from the routing rules: clinical studies to the clinical owner, stability and assays to CMC, registries and observational studies to real-world evidence, EU obligations to the EU regulatory lead. Inherited records without a functional owner are raised as a risk.
Every morning at 06:00 checks each open milestone and internal target, alerts the owners at the lead times in Settings, raises a slip when an internal target is missed and escalates 30 days out when no draft or evidence exists.
Drafts annual status tables, 180-day progress reports and EU obligation updates from the register: original and current schedule, the agency's status category and a short factual explanation, with citations.
Confirms each date and signs. The agents propose; a named person decides.
Ask in plain words — or tell it what to change. Every answer points to the letter and page it came from.
Did we promise anything in meetings that is not on the timeline?
Yes, one. In the Type C minutes of May 20 for Veltrimab, page 2, Northwind agreed to submit a shipping validation report for the 200 mg/mL syringe by Mar 31, 2027. It sits in the discussion of Question 3, not the action items, and the minutes were filed on Jun 19 with no timeline entry.
Which commitments came with Nexarin from Halden?
Four, transferred on Sep 2 with the Halden Therapeutics acquisition. Two have no functional owner. The extractables and leachables study is due Dec 31 and has had no status since July.
Draft the Veltrimab annual status table
BLA 761412 reaches its approval anniversary on Oct 21, so the status report is due Dec 20, 2026 — 60 days later, under 21 CFR 601.70. The Status Reporter writes one row per requirement and commitment with the agency's status words and the evidence. One item will need a decision: the HMW limits re-evaluation cannot meet Oct 31.
Add a rule: alert me 120 days before any EU specific obligation
Done. Every EU specific obligation now alerts 120 days ahead as well as at the usual lead times (90, 60, 30 and 7 days). It applies to 3 open obligations today — Talmirex SOB 001, SOB 002 and Nexarin SOB 001. Alerts go to Priya Raman, and the rule is in Settings and on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Alerts, who signs, how work is routed and which rules are locked are settings, on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Lead times | 90, 60, 30 and 7 days | 120 · 90 · 60 · 30 · 7 days, each on or off |
| Escalate to the regulatory lead | On — 30 days out with no draft or evidence | On · Off |
| Weekly digest to owners | On — Monday 08:00 | On · Off |
| New commitments from letters | Omar Haddad confirms and signs | Omar Haddad · Priya Raman · Dana Okafor · Sam Patel |
| Changes to dates or scope | Omar Haddad + Dana Okafor | Omar Haddad + Dana Okafor · Omar Haddad · Priya Raman · Dana Okafor · Sam Patel |
| EU obligations and renewals | Priya Raman | Priya Raman · Omar Haddad · Dana Okafor · Sam Patel |
| Track promises in minutes and question responses | On | On · Off |
| A commitment closes only when the agency confirms fulfilment | On, locked | Locked on |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = the working solution's own estimate before deployment. Regulations named as context: 21 CFR 314.81(b)(2)(vii) and 601.70 (annual status reports); FD&C Act 505(o)(3), 505B and 506B; EU post-authorisation measures. People, companies, products and documents named on this page are fictional — characters and sample data in the working solution.
Keeping every postmarketing requirement and commitment, EU obligation and local approval condition on record with its dates, owners and status until the agency confirms it is fulfilled. Post-Marketing Commitment Tracking does it with agents that read every approval letter, set of minutes and question response and put each item on one timeline by product, with the agency's exact words and the page.
The Promise Finder reads minutes and question responses — the discussion as well as the action items — for sentences such as “the sponsor agreed to” or “Northwind commits to”, and checks each against the timeline. It re-reads a product's file when a letter arrives or the product gets a new approval, and shows which promises are already on the timeline and which are not.
Yes. The register holds US requirements and commitments, EU specific obligations, Annex II conditions and post-authorisation measures, and local conditions from agencies such as PMDA, Swissmedic, Health Canada, TGA, MHRA and ANVISA. The same study is linked across markets, and EU obligations are routed to the EU regulatory lead.
Yes. For each application the Status Reporter drafts the status of every postmarketing requirement and commitment — original and current schedule, the agency's status category and a short explanation with its evidence — due 60 days after the approval anniversary under 21 CFR 314.81(b)(2)(vii) and 601.70. It also drafts 180-day progress reports and EU obligation updates. Regulatory operations reviews and the regulatory lead signs.
Every morning the Deadline Monitor checks each milestone and internal target. Owners are alerted at 90, 60, 30 and 7 days by default, a slip is raised the day an internal target is missed, and the regulatory lead is told 30 days out when there is no draft or evidence.
Yes. The agents propose and never add, change or close anything themselves. The regulatory lead signs every entry, compliance countersigns any change to a date or scope, and a commitment closes only when the agency confirms fulfilment.
No. It reads correspondence from your registrations archive and works as the commitments register your team works in every day; the registration system remains the system of record.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your approval letters, minutes, responses and current commitments tracker — and it goes live once every quality gate has passed. We will walk you through it on your own correspondence first.
Every agency change reaches the right team within hours, with what changed marked.
1-min demoCTD Module 2 AuthoringModule 2 summaries drafted in weeks, every statement cited to its source.
1-min demoHealth Authority Query ResponseCited first drafts within hours, consistent with every past answer to every agency.
1-min demoWe'll run Post-Marketing Commitment Tracking on a sample of your own approval letters, minutes and responses.