Cold chain and clinical supply logistics for pharma and biotech
Stay ahead of the compliance and cold chain risks that come with fragmented systems. Agistix connects temp-controlled execution, chain-of-custody documentation, and CMO visibility in one platform.
Documentation, visibility, and compliance on every shipment
Cold chain execution and monitoring
Temperature-controlled execution across refrigerated, frozen, ultra-low, and cryogenic ranges.
- Connects to qualified temperature-controlled carriers across LTL, air cargo, and last-mile providers
- IoT and telemetry integrations capture device-level temperature data with configurable threshold alerts
- Temperature data and excursion events logged automatically for GDP deviation investigations
Chain-of-custody and serialization visibility
Transaction documentation and chain-of-custody tracking on every pharmaceutical shipment.
- Captures and stores DSCSA-required transaction information, history, and statements against every shipment record
- Serialization and lot-level data flow alongside carrier tracking events
- Document retrieval is on demand when FDA requests records
Controlled substance workflows
Compliant routing and documentation workflows for DEA Schedule I-V materials.
- Routes DEA-scheduled shipments through carrier networks with controlled substance transport qualifications
- Proof of delivery, chain-of-custody acknowledgments, and carrier security certifications stored on the shipment record
- Compliance checkpoints surface documentation gaps before a shipment tenders
CMO and clinical trial supply visibility
Real-time status on shipments moving between contract manufacturers, packagers, and clinical sites worldwide.
- Surfaces real-time status across CMOs, contract packagers, and clinical trial sites alongside internally managed freight
- Investigational medicinal product shipments carry lot and expiry data through the shipment record
- Configurable exception alerts notify study teams when a clinical supply shipment misses a milestone or is held at customs
Real customers, real results
A Fortune 500 healthcare leader achieved 30% year-over-year savings by reducing unnecessary expedited shipments and gained 95% on-time performance visibility across integrated carriers with Agistix.
Read the case study →More to explore across the platform
The world is taking notice
See Agistix in action
See how Agistix supports pharmaceutical and biotech logistics from cold chain execution through compliance documentation.
FAQs
How does Agistix support GDP-compliant temperature-controlled logistics?
Agistix supports cold chain execution across all temperature ranges with carrier connectivity to qualified temperature-controlled providers. IoT and telemetry integrations capture device-level temperature data at the shipment level. Excursion events and sensor data are logged automatically to the shipment record, giving QA teams the deviation documentation required under EU GDP and FDA guidelines.
Can Agistix support DSCSA chain-of-custody requirements?
Yes. Agistix captures and stores DSCSA transaction information, transaction history, and transaction statements against every pharmaceutical shipment record. Serialization and lot-level data flow alongside carrier tracking events, giving logistics and compliance teams a complete chain-of-custody picture from manufacturer to dispensing location.
Does Agistix handle Schedule I-V controlled substance shipments?
Agistix routes DEA-scheduled shipments through qualified carrier networks and enforces documentation requirements at booking. Chain-of-custody acknowledgments, proof of delivery, and carrier security certifications are stored on the shipment record. Compliance checkpoints in the workflow surface documentation gaps before tender.
Can Agistix integrate with pharma ERP and quality management systems?
Yes. Agistix integrates with leading ERP platforms including SAP, Oracle, and Microsoft Dynamics, as well as WMS and quality management systems via REST API, EDI, and sFTP. Shipment data, documentation, and exception events flow bidirectionally so logistics execution stays in sync with batch records and QMS workflows.
How does Agistix handle dangerous goods for pharma shipments such as dry ice and cryogenic materials?
Agistix supports dangerous goods shipping under 49 CFR, IATA DGR, and IMDG, including Class 9 materials such as dry ice and cryogenic liquids. Carrier routing enforces DG certification requirements, and hazmat documentation is generated and stored on the shipment record automatically.