A drug shortage early warning system that ranks every market by weeks to stock-out and shows the record behind each driver
Ranked, cited shortage alerts raised weeks before stock runs out.
See one case, screen by screen ↓Software that watches the signals that can take a medicine off the shelf and warns the supply team before stock runs out. Drug Shortage Early Warning reads the manufacturer's own planning export, quality records, CMO notices and shipment exceptions, projects each product-market 16 weeks ahead and ranks alerts by cited drivers, for the continuity lead to confirm and sign.
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The signals that take a critical medicine off the shelf arrive in four places at once: the planning export, the quality system, the supply mailbox and the shipment exception feed. A deviation puts a lot on QA hold, a temperature excursion quarantines a shipment, a tender adds demand, and a CMO emails that a fill date has moved. Each is read by a different team, and nobody rebuilds the market's projected cover with all of them taken out at once.
So a CMO delay email can sit unread for a day while a QA hold and a tender quietly eat the same weeks of cover, and the stock-out is found at the weekly S&OP, or at the pharmacy counter. Meanwhile the clocks have started: FDA section 506C wants notice no later than five business days after an unforeseen interruption likely to meaningfully disrupt supply, and in the EU, marketing authorisation holders now report shortages through the European Shortages Monitoring Platform, mandatory since February 2025.
Estimated split for one supply signal on a Tier 1 product-market, by hand and with the solution.
Six specialist agents read stock, quality, supplier and shipment signals, move each market on the radar and draft the plan; the continuity lead signs.
Northwind Bio watches 48 product-markets of seven critical medicines. On Oct 7 at 09:18 its contract fill-finisher emails a delay notice for the lot that fills the German Veltrimab 40 mg pen. Here is what happens next, screen by screen, in the working solution.
Each sector is a product, each dot a market, and the distance from the centre is the weeks to the projected stock-out. The 05:42 sweep has scored all 48 product-markets. Veltrimab 40 mg pen in Germany is already open as A-2611, risk 61: under safety stock Nov 16, lowest cover 0.6 weeks on Dec 14, no stock-out projected. Above the radar, a Halvorsen Fill-Finish delay notice for lot 2614 has arrived and is marked not read yet.
Drivers, ranked by weeks of cover lost: lot VLT-P-2611 on QA hold −1.7 wk · shipment SH-77421 quarantined −1.1 wk · regional tender adds 18% demand −0.8 wk.
Below the radar, each alert's projected stock runs week by week with the at-risk receipts taken out and safety stock as the amber line. Veltrimab 80 mg vial in Italy breaks safety stock Nov 9; Talmirex in the US runs out Dec 21 if nothing is done; Corventa 15 in Brazil, Tessilor in France and Quorvanex in Japan are shown with their approved plans.
The notice reader reads the email on screen and pulls the lot, the dates and the quantity: lot 2614 fill moves Oct 26 → Nov 16 and ships Dec 14, 6,000 pens three weeks late. It matches the lot to the German pack, and the risk scorer rebuilds the projection. Germany rises from risk 61 to 86, moves inward to the 8-week ring and turns red.
“Runs out Nov 30 · In 54 days · 7.7 weeks if nothing is done.”
The CMO delay is now driver 1, with a citation to the supply mailbox, Oct 7 09:18. Opening it shows the email with the passage the agents cite highlighted: a syringe barrel shortfall at Halvorsen's sub-supplier after a furnace repair. A second passage offers a way out — lot 2614 can ship Dec 4 if air freight is acceptable.
“Read-only copy · the highlighted passage is the one the agents cite.”
The alert ranks four drivers, each with its record: the CMO delay and lot VLT-P-2611 on QA hold for visible particles at AQL inspection (DEV-26-0418, 6,000 pens) at −1.7 weeks each, SH-77421 quarantined after its logger read 9.4 °C for 47 minutes at −1.1 weeks, and the health-insurer tender at +560 pens a week. Projected stock-out Nov 30, lowest cover −0.5 weeks, first week under safety stock Nov 16.
“Agents raise alerts; a person confirms or dismisses.”
The planner drafts options from the network, each with an owner, a cost and the weeks of cover it buys: reallocate 4,200 pens from the Netherlands and Austria (+1.2 wk), QA priority on DEV-26-0418 to release 5,400 pens Nov 16 (+1.5 wk), air-freight lot 2614 (+1.7 wk). With the recommended set the stock-out goes from Nov 30 to none and lowest cover from −0.5 to 1.8 weeks.
“Moves 24% of Austria’s buffer — Omar Haddad approves.”
The confirmation shows the alert, the three options with their owners and the result: no stock-out, lowest 1.8 weeks. Lena signs with the meaning “I confirm this supply risk and approve the plan” and her password. Because Austria gives more than a fifth of its buffer, the request for Omar Haddad's second approval goes out with her signature.
“Signed as Lena Ortiz · Supply continuity lead · Oct 7 09:24 · recorded in the decision log.”
The decision is recorded, and tasks go to Priya Raman for the reallocation, Dana Okafor for the QA priority and Sam Patel for the air freight. The second approval waits with Omar Haddad. With no stock-out projected, the authority notice is not needed and the rationale is recorded. The alert moves to Mitigating until cover holds above safety stock for four weeks.
A force majeure notice from Kestrel Fine Chemicals — reactor R-4 shut down Oct 2, API lots K-77 to K-79 about six weeks late — puts Talmirex 100 mg/10 mL vials in the US on course to run out Dec 21. The authority notice tab counts the business days to Oct 9 and the notice writer drafts the 506C fields from the cited records, down to the reason, the expected duration and the contact.
“The notice writer drafts from the alert and its records; regulatory affairs files.”
Running the watch reads the latest signals in parallel. A Rotterdam port delay of one day has no supply impact; a DEV-26-0418 update says the deviation is contained to tray 4 and links to A-2611; a Plant 2 schedule change moving the Spanish pack run of Corventa 15 mg to Nov 9 raises A-2613, risk 47. The planner drafts one option, and the alert waits for Lena to confirm or dismiss.
The same shortage, seen by the people who carry it — what their week looked like, and what it looks like now.
Six specialist agents read stock, quality, supplier and shipment signals, move each market on the radar and draft the plan; the continuity lead signs.
Reads the daily planning export — projected inventory, receipts and demand for 48 product-markets over 16 weeks — computes weeks of cover and flags any week under safety stock, or any change of more than 5% in receipts or demand since yesterday.
Watches the quality system every hour for batch holds, deviations, OOS results and certification queues, and maps each batch to the market packs it blocks, with quantity and expected release.
Reads the supply mailbox — delay notices, force majeure letters, capacity letters — and pulls the supplier, lot, old and new date and quantity, quoting the passage. Price lists and routine letters are marked not a supply signal.
Reads the shipment exception feed every 15 minutes — temperature excursions with the logger reading and the product's stability budget, customs holds, missed pick-ups — and finds the stock that is in doubt.
Rebuilds each product-market's 16-week projection with at-risk receipts moved and demand changes applied, reports lowest cover, the first week under safety stock and the stock-out week, attributes weeks lost to each driver and scores 0–100 by depth, timing and criticality tier.
Drafts options from the network — reallocation, QA priority, faster freight, registered alternate sites, demand phasing — each with its effect on cover, cost and owner, recommends the smallest set that holds safety stock, and drafts the FDA 506C notice or EU shortage report when a shortage stays likely.
Confirms and approves. The agents propose; a named person decides.
Ask in plain words, or say what to watch. Every answer points to the record behind it.
Why is Veltrimab in Germany at risk?
Veltrimab 40 mg pens in Germany are projected to run out on Nov 30. Four things land on the same six weeks: the CMO delay on lot 2614 and the QA hold on lot VLT-P-2611 (6,000 pens and 1.7 weeks each), the quarantined shipment SH-77421 (3,800 pens, 1.1 weeks) and the regional tender (2,800 pens, 0.8 weeks). The recommended plan — reallocate 4,200 pens from the Netherlands and Austria, QA priority on the deviation, air-freight lot 2614 — keeps cover above safety stock.
What happened to shipment SH-77421?
SH-77421 (3,800 Veltrimab pens, Leiden → Frankfurt) logged 9.4 °C for 47 minutes at a border stop and is quarantined. The product allows up to 72 hours cumulative at 8–25 °C, so QA can likely release it once the logger file is checked — that option is in the German plan. Until QA decides, the agents count it as lost.
Where can we take stock from?
For Veltrimab pens the planner found 4,200 pens that can move to Germany by Nov 2 while every donor keeps more than 6.5 weeks: 2,400 from the Netherlands (6.9 weeks after) and 1,800 from Austria (7.1 weeks after). Austria gives 24% of its buffer, so Omar Haddad’s second approval goes out with your signature.
Draft the FDA notice for Talmirex in the US
Talmirex in the US needs a decision on the FDA 506C notice by Oct 9 — five business days after the API supplier’s reactor shutdown on Oct 2. If nothing is done, US stock runs out Dec 21, which counts as a likely meaningful disruption. I am drafting the notice on the alert now; regulatory affairs files it.
13 screens from the working solution, on its sample data. Pick one to see it large.
When the agents raise an alert, what they watch and who decides are settings, applied at every sweep.
| Setting | Default | Choose from |
|---|---|---|
| Tier 1 — alert when cover will break safety stock within | 16 weeks | 6 to 26 weeks, in steps of 2 |
| Tier 2 — alert when cover will break safety stock within | 10 weeks | 4 to 20 weeks, in steps of 2 |
| Minimum risk score to raise an alert | 40 | 20 to 80, in steps of 5; lower scores are kept as watch notes |
| Safety stock for Tier 1 products | 2 weeks of forward demand | 1 to 6 weeks |
| What the agents watch | Planning export, quality system, supply mailbox, shipment exception feed | Each on or off · customs broker portal and market intelligence off |
| Confirm alerts | Europe and International: Lena Ortiz · Americas: Sam Patel | A named approver per region (Priya Raman or Lena Ortiz as alternates); confirms or dismisses, approves the plan |
| Reallocation of more than 20% of a market’s buffer | Second approval: Omar Haddad | Omar Haddad or Lena Ortiz, before stock moves between markets |
| Authority notices (FDA 506C, EU shortage reports) | Hannah Weiss | Hannah Weiss or Priya Raman; the notice writer drafts, regulatory affairs files |
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 supply data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (ASHP drug shortage statistics, year-end 2025 — 216 active US shortages; FDA section 506C guidance — five business days after an unforeseen interruption; EMA European Shortages Monitoring Platform, mandatory since February 2025). People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that watches the signals that can take a medicine off the shelf and warns the supply team before stock runs out. Drug Shortage Early Warning reads the manufacturer's own planning export, quality records, CMO notices and shipment exceptions, projects each product-market 16 weeks ahead and ranks alerts by cited drivers, for the continuity lead to confirm and sign.
The risk scorer rebuilds each product-market's 16-week projection with at-risk receipts moved to their new dates and demand changes applied. It reports the lowest cover, the first week under safety stock and the stock-out week, attributes weeks lost to each driver and scores the risk from depth, timing and the product's criticality tier.
Yes. The Supplier & CMO notice reader reads the supply mailbox, extracts the lot, the old and new dates and the quantity, and quotes the sender's passage. Unclear notices go to a person, and price lists or routine letters are marked as not a supply signal.
When a shortage stays likely after the plan, the notice writer drafts the FDA 506C notice or the EU shortage report from the cited records, and the alert shows the business days left. Regulatory affairs reviews and files; the agents never contact an authority.
No. Held and quarantined stock is treated as at risk until QA releases it, and the agents never release it. A temperature excursion is shown with the product's stability budget, so QA can decide.
Yes. Agents raise alerts and draft plans; the continuity lead confirms or dismisses with a signature that records name, time and meaning. Moving more than 20% of a market's buffer needs a second approval from the head of supply-chain risk, and every dismissal keeps its reason.
Yes. The alert window for each criticality tier, the minimum risk score, Tier 1 safety stock, the sources watched and the approvers by region are settings. A new rule can also be described in plain words, such as alerting when a Tier 1 product drops under 6 weeks of cover.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your critical product list, planning exports, quality records and a sample of supplier notices — and it goes live once every quality gate has passed. We will walk you through it on your own data first.
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1-min demoWe'll run Drug Shortage Early Warning on a sample of your own planning exports, quality records and supplier notices.