Post-marketing commitment tracking — every promise to a health authority, in the agency’s words, on one register
Every promise made to a health authority sits in one register with its exact words and page, and its owner hears 90 days before it falls due.
See one case, screen by screen ↓Every approval leaves a trail of promises: PMRs and PMCs in the FDA letter, specific obligations and RMP measures in the EU, conditions on a PMDA or Swissmedic approval, and the things the team agreed to in a Type B meeting or a question response. They arrive in different letters, in different markets, and are copied by hand into a spreadsheet — often reworded on the way.
Then the dates have to be watched. A supplement approval quietly revises an existing PMR. A study runs short of lots and cannot meet its date. Commitments come in with an acquired product and no owner. And once a year, 60 days after each approval anniversary, someone has to chase every owner, cross-check the register against the archive and the letters, and write a status line for each item.
Estimated hours for one application’s status table, compiled by hand and drafted from the register — the working solution’s own estimate.
Specialist agents read every letter, find and match each commitment, watch the dates and draft the status reports; the regulatory lead confirms and signs.
On Oct 6 the FDA’s supplement approval for Veltrimab in Crohn’s disease (BLA 761412/S-008) lands in the regulatory mailbox. Here is what happens next, screen by screen, in the working solution.
Omar opens the Horizon: 29 open commitments to 8 health authorities across 4 products, every milestone laid out by product for the next 12 months. The nearest clocks sit across the top — the 180-day progress report on TLX-301 is due in 7 days, the HMW species limits re-evaluation in 24. Six things wait for him.
Needs you: “Sign 3 items from the Veltrimab S-008 letter — FDA supplement approval · 1 is a change to CMT-101.”
Omar opens the new FDA letter. The Correspondence Reader records it as a supplement approval letter for Veltrimab, FDA, 3 pages. The Commitment Extractor finds 3 items with page anchors and sets a standing reminder aside; the Change & Duplicate Checker sees that one of them changes CMT-101; the Owner Router proposes owners. Each passage is highlighted in the letter as it is found.
“Nothing enters the register until you sign.”
The first item is PMR 4512-7, a deferred paediatric study under PREA: “Conduct a study to evaluate the pharmacokinetics, safety, and efficacy of Veltrimab in pediatric patients 6 to 17 years of age with moderately to severely active Crohn’s disease.” Page 2, 97 % confidence, with its three dates — final protocol 03/2027, study completion 06/2030, final report 12/2030 — and Dr. Maya Chen proposed as the functional owner.
Agent limit: wording is copied exactly — never paraphrased — and every item carries its page.
The letter says PMR 4512-1 “is revised as follows”. The checker matches it to CMT-101, the pregnancy exposure registry, and shows the difference: “women with ulcerative colitis” becomes “women with ulcerative colitis or Crohn’s disease”. The schedule is unchanged — final report 06/2032. Omar can apply it to CMT-101, add it as a new record, or reject it. The adverse experience reporting reminder (21 CFR 600.80 / 600.81) is marked as not a commitment, so nothing is added.
Omar confirms the paediatric study and the ADA assay commitment, applies the revised wording to CMT-101 and agrees the reminder adds nothing. He signs with his password and the meaning of the signature — “I approve these register entries”. Because one item changes an existing commitment, it also goes to Dana Okafor in compliance for countersignature; the original wording stays in the record history.
CMT-113, CMT-101 and CMT-114 are updated in the register. Dr. Maya Chen, Claire Dubois and Lena Ortiz are notified as owners, and alerts are scheduled at 90, 60, 30 and 7 days before each milestone. Every agent step and every decision is written to the audit trail.
“Signed and in the register. CMT-113 · CMT-101 · CMT-114 — owners notified, alerts scheduled at 90, 60, 30 and 7 days.”
BLA 761412 reaches its approval anniversary on Oct 21, so the status report is due Dec 20 under 21 CFR 601.70. The Status Reporter writes one row for each of the 8 requirements and commitments — original and current schedule, the agency’s status category and a short explanation with its evidence. The two new items from S-008 go in as Pending. One does not fit: PMC 4512-6 is Delayed, with no revised date yet.
Agent limit: Submitted is never written as fulfilled; a delayed item always carries a reason and a revised date.
PMC 4512-6 asks for the HMW species limits to be re-evaluated after 30 commercial lots, with the CBE-30 final report due Oct 31. Only 21 lots have been made; the 30th is planned for Feb 2027. On Oct 5 at 06:00 the Deadline Monitor compared Lena Ortiz’s internal targets with plan, saw three of them missed, and raised the slip on the record more than three weeks before the agency date.
“The Oct 31 date cannot be met — a revised date and an explanation are needed in the annual report.”
Omar asks for a new date of May 31, 2027 and presses “Draft it for me”. The Deadline Monitor reads the progress and the cause of the slip; the Status Reporter writes the reason: demand for the 200 mg/mL presentation was lower than forecast, the 30th lot is scheduled for February 2027, and the revised final report submission is 05/2027. He signs and applies it, and it goes to Dana Okafor for countersignature.
“Reported as Delayed with this explanation in the next annual status report; the agency is also told by letter now.”
The dashboard shows what is owed and where the risk is: 31 open commitments after the S-008 letter, 93 % of milestones met on time this year (37 of 40), 12 due in the next 90 days with 3 at risk, and 31 letters read by the agents with 46 items found, each one signed.
The same register, seen by the five people who keep it — what their year looked like, and what it looks like now.
Specialist agents read every letter, find and match each commitment, watch the dates and draft the status reports; the regulatory lead confirms and signs.
Reads every incoming letter, set of minutes and response, and works out the agency, document type, product, application number and letter date.
Finds every requirement, commitment, condition and promise — including “the sponsor agreed to” in minutes — and keeps the exact wording, the page, the legal basis and every date.
Matches each item against the register: new, a change to an existing record with the wording and date differences, or a status event such as fulfilled or released.
Proposes the regulatory owner and the functional owner from the routing rules, and raises inherited records with no functional owner as a risk.
Checks every open milestone and internal target every morning, alerts owners at the lead times, raises slips and escalates to the regulatory lead 30 days out when no draft or evidence exists.
Drafts annual-report status tables, 180-day progress reports and EU obligation updates from the register, with a citation for every status.
Confirms each item and signs. The agents propose; a named person decides.
Anyone on the team can ask in plain words — or tell it what to change. Answers come from the letters, minutes and responses behind the register, with the page each commitment came from.
What is due in the next 60 days?
Five milestones: the TLX-301 180-day progress report (Oct 14, Sam Patel), the HMW species limits re-evaluation (Oct 31, Lena Ortiz), the TGA extension of provisional registration (Nov 18, Sam Patel), the PMDA all-case use-results survey report (Nov 30, Claire Dubois) and the Swissmedic final CSR of CRV-401 (Nov 30, Dr. Maya Chen). The Talmirex progress report is the tightest — no draft yet.
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.
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. The rule is on in Settings and in the audit trail.
Draft the Veltrimab annual status table
Starting it now. 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.
13 screens from the working solution, on its sample data. Pick one to see it large.
Lead times, who signs what, and who owns which kind of commitment are settings — changed in a click and saved to the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Owners are alerted before each milestone | 90 · 60 · 30 · 7 days | 120 · 90 · 60 · 30 · 7 days |
| Raise a slip the day an internal target is missed | On | On · Off |
| Escalate to the regulatory lead | 30 days out with no draft or evidence | On · Off |
| Weekly digest to owners | Monday 08:00 | On · Off |
| Who signs new commitments from letters | Omar Haddad | 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 | Omar Haddad · Priya Raman · Dana Okafor · Sam Patel |
| Routing rules | 7 rules | Each on or off — e.g. stability, assays and specifications → Lena Ortiz |
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 portfolio data · “target” = the design goal, measured in the live solution · “estimated” = the solution’s own estimate before deployment. Regulatory references: 21 CFR 314.81(b)(2)(vii) and 601.70 (annual status reports) · EU post-authorisation measures. People, products and companies named on this page are characters in the working solution.
A single register of everything a company owes health authorities after approval — postmarketing requirements and commitments, EU specific obligations and RMP measures, local conditions and promises made in meetings — with the schedule, owners and status of each. The Commitments & Obligations Register builds and keeps it from the letters themselves, with the agency’s exact words and page on every entry.
The Commitment Extractor reads each letter, set of minutes or question response and finds every sentence that creates an obligation, including promises such as “the sponsor agreed to”. It copies the wording exactly, records the type, legal basis, market, dates and page, and marks standing reminders as not a commitment.
No. The agents propose; the regulatory lead confirms, edits or rejects each item and signs before anything enters the register. A change to a date or scope needs a reason and a countersignature from compliance, and the earlier version stays in the record history.
Yes. For each application it drafts the status of every postmarketing requirement and commitment, due 60 days after the approval anniversary under 21 CFR 314.81(b)(2)(vii) and 601.70 — original and current schedule, the agency’s status category and a cited explanation. Regulatory operations reviews it and the regulatory lead signs. It also drafts 180-day progress reports and EU obligation updates.
Yes. The register holds EU obligations and measures (SOB, ANX, MEA, REC and conditional MA renewals) and local conditions from agencies such as PMDA, Health Canada, Swissmedic, TGA, MHRA and ANVISA. When a date has to move, it says how: for the EU, tell EMA and the rapporteur in writing before the due date.
Only when the agency confirms fulfilment. A submitted final report moves the item to Submitted. When the agency’s fulfilment letter arrives, the agents read it like any other letter and propose the status change, and the regulatory lead applies and signs it.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your approval letters, minutes, responses and routing rules — and it goes live once every quality gate has passed. We will walk you through it on your own letters first.
Yes. Every register entry is confirmed and signed by a named person, owners are proposed and then confirmed, and the agents cannot close a commitment or overwrite a record. Every step and decision is on the audit trail.
Every agency change reaches the right team within hours, translated and cited.
1-min filmSubmission SummariesModule 2 summaries drafted in weeks, every statement cited to its source page.
1-min filmAgency ResponsesEvery agency question gets a cited first draft within hours, consistent with every past answer.
1-min filmWe’ll run the Commitments & Obligations Register on a sample of your own approval letters, minutes and responses.