Now accepting design partners
The shipment is always watched.
KOLD replaces passive temperature trackers and manual compliance logs with a continuous, AI-driven thermodynamic audit layer — and pays out insurance claims automatically when excursions occur.
$35B
Annual perishables waste from excursions
12h → 3s
Manual compliance log → automated report
100%
Regulatory coverage: GDP, FDA 21 CFR Part 11, FSMA
$5M+
Maximum batch loss per temperature excursion
The problem
EXCURSION — 01
A single excursion destroys the batch
One temperature deviation — often undetected for hours — can void a pharma shipment worth $50K to $5M+. Passive trackers log the damage; they do not prevent it.
EXCURSION — 02
Manual logs fail GDP audits
Compliance teams spend days reconstructing shipment records from spreadsheets, paper logs, and disconnected tracker exports. Auditors reject them. Regulators fine you.
EXCURSION — 03
Insurance claims take weeks
The standard cold chain claim process involves manual documentation, adjuster review, and settlement cycles measured in months. You absorb the loss first.
The platform
Three systems.
One continuous audit trail.
KOLD-SCAN
Real-time shipment telemetry
Per-shipment IoT sensors capture continuous temperature, humidity, light, and tilt data. The proprietary excursion model detects deviations with higher fidelity than threshold-based alerts — predicting risk before it becomes a loss.
Sensor resolution±0.1°F
Update interval30s
Alert latency< 60s
KOLD-FORM
Automated compliance documentation
Every sensor reading is mapped to GDP, FDA 21 CFR Part 11, and FSMA requirements in real time. Audit-ready documentation is generated automatically — no spreadsheets, no manual reconstructions, no last-minute scrambles.
Regulations coveredGDP · FDA · FSMA
Report generation< 3s
Audit pass rateTarget 100%
KOLD-ASSURE
Parametric insurance payouts
When a verified excursion event is recorded by KOLD sensors, the parametric insurance layer triggers an automatic payout — no manual claims process, no adjuster, no 90-day wait. The claim resolves in seconds.
Payout triggerAutomated
SettlementSeconds, not months
Evidence chainSensor-verified
Who it's for
Built for regulated cold chains.
Not general logistics.
Pharma & biologics manufacturers
VP Supply Chain · Head of QA · Regulatory Affairs
KOLD is purpose-built for mid-to-large pharma companies shipping temperature-sensitive biologicals, vaccines, and specialty drugs under GDP and FDA Part 11 obligations.
Trigger: Upcoming GDP audit, recent excursion loss event, or insurer mandate
3PL and specialty logistics
Director of Operations · Compliance Manager
For logistics providers who need to demonstrate continuous chain-of-custody to pharma customers and insurers across complex, multi-leg shipment routes.
Trigger: Carrier liability exposure, client audit requirements
Biopharma CROs
Regulatory Affairs · Clinical Supply Chain
Clinical research organizations transporting investigational products under strict temperature protocols where a single deviation risks trial invalidation.
Trigger: Clinical trial shipment integrity, investigational product compliance
Design partner program
Pilot KOLD on your highest-value
shipping lanes. First.
We are onboarding a small cohort of pharma and biologics companies as design partners. You get early access to the full KOLD platform, direct input on the roadmap, and a reference-customer arrangement that works for both sides.
REQUEST ACCESS
Pharma & biologics companies only · Q3 2025 pilot cohort