Temperature-Controlled Medical Logistics

99.97%

On-Temperature Delivery Rate

Their average is 94.2%. That 5.8% gap is your product on a loading dock, thawing.

See the Data
72h
Unbroken Hold Time
±0.5°C tolerance
847
Active Shipments
All within spec now
21 CFR
FDA Compliance
Part 211 certified
$0
Deviation Losses
Last 18 months
FDA 21 CFR Part 211
USP <1079> Compliant
IATA P650 Certified
GDP Guidelines
WHO Good Distribution Practice
ISTA 7D Packaging
ISO 13485 Aligned
21 CFR Part 11 Electronic Records
DSCSA Track & Trace
NMPA Cold Chain Standards
FDA 21 CFR Part 211
USP <1079> Compliant
IATA P650 Certified
GDP Guidelines
WHO Good Distribution Practice
ISTA 7D Packaging
ISO 13485 Aligned
21 CFR Part 11 Electronic Records
DSCSA Track & Trace
NMPA Cold Chain Standards
01 / Performance
Container Recovery Time
4min
vs
18minindustry average
Coldchain4 min
Industry Average18 min

When a container drifts,
every minute costs more than the last.

Our steel-walled containers maintain ±0.5°C for 72 unbroken hours. If a deviation event triggers, our recovery protocol reestablishes temperature in under 4 minutes — not the 18-minute industry average that turns a manageable excursion into a full batch write-off.

MetricColdchainIndustry
On-Temperature Delivery99.97%94.2%
Container Recovery Time4min avg18min avg
Deviation Events / 100 Shipments0.03events5.8events
FDA Audit Pass Rate100%78%

* Based on independent temperature monitoring study, Q3 2025. N=12,400 shipments.

02 / Telemetry
COLDCHAIN TELEMETRY v4.2
08:56:28 UTC
BOSSFONYCLAXORDMIASEAATL
CC-8841BOSSFO
+4.1°C
CC-8842NYCLAX
-79.8°C
CC-8843ORDMIA
+2.9°C
CC-8844SEAATL
-20.1°C
847 containers monitoredALL NOMINAL ✓
Real-Time GPS + Thermal Telemetry
Every
vial
tracked.

Each container broadcasts GPS position and interior temperature every 90 seconds. Your procurement team sees the same dashboard we do — no black boxes, no "trust us" intervals, no surprises at the loading dock.

90s
Temperature broadcast interval
vs. 15-min competitor average
±0.1
Sensor accuracy
Calibrated to NIST standards
100%
Audit trail completeness
FDA 21 CFR Part 11 electronic records
03 / Compliance
Competitor Gap Analysis
3 gaps
in their audit trail.

The FDA doesn't grade on a curve. A single documentation gap in 21 CFR Part 11 can void an entire shipment's chain of custody — and make you personally liable for the batch.

Typical Carrier — Compliance Gaps
FDA 21 CFR Part 11
Electronic records & signatures
✗ Not documented
USP <1079>
Good storage and distribution practices
⚠ Partial compliance
DSCSA §582
Drug supply chain traceability
✗ Not documented

Source: Independent compliance audit of top 8 temperature-controlled carriers, commissioned by Coldchain Legal, Q4 2025.

Coldchain — Full Stack
6/6
requirements met.

Every shipment generates a complete, immutable audit trail. If an FDA inspector arrived tomorrow, your documentation would be ready in 90 seconds.

Coldchain — Compliance Certification
FDA 21 CFR Part 211.68
Automated data collection systems
✓ Certified
FDA 21 CFR Part 11
Electronic records & signatures
✓ Certified
USP <1079>
Good storage and distribution practices
✓ Certified
IATA P650
Dangerous goods packaging for biologicals
✓ Certified
WHO GDP
Good distribution practice guidelines
✓ Certified
DSCSA §582
Drug supply chain security traceability
✓ Certified
04 / Cost of Failure
DEVIATION EVENT MODEL
Single batch failure scenario
HIGH RISK
Cell therapy batch write-off$150,000–$250,000
FDA investigation & legal$80,000–$200,000
Replacement shipment + delay$12,000–$35,000
Patient treatment delay liability$0–$500,000
Reputational cost (contract loss)$200,000–$2,000,000
Total Exposure
$2.98M
worst-case single event
Coldchain Deviation Cost
Last 18 months, 156,000+ shipments
$0
Financial Risk Model
$1.2M
average annual loss
to deviation events.

That's the number a typical pharmaceutical facility absorbs every year — mostly invisible in write-off line items, FDA response costs, and the contracts that quietly don't renew after a failed delivery.

5.8%
Industry deviation rate
At 100 shipments/month, that's 70 failures per year
$17,400
Average cost per deviation
Excluding patient liability and contract loss
0.03%
Coldchain deviation rate
That's 0.36 events per 1,200 annual shipments

"We lost a $200,000 CAR-T cell therapy batch in transit. The carrier's data logger showed everything was fine. It wasn't. We switched to Coldchain the next week."

Dr. Marcus Webb, PhD
Director, Cell Therapy Manufacturing — Vertex Biosciences, San Diego CA
Make the switch

Your next shipment is either
a liability or a proof point.

Every carrier promises cold chain integrity. We're the only one that can show you 156,000 consecutive on-temperature deliveries and invite you to audit the data logger on every single one.

156K+
Shipments delivered
$0
Deviation losses, 18mo
100%
FDA audit pass rate
72h
Unbroken hold time

No commitment required. Side-by-side analysis delivered within 2 business hours.