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Case Study: A European Pharma Company Needs An Importer Of Record

Warehouse Technician loads truck with API product.
WDSrx Warehouse Technician loads API pallets for fulfillment.

Watch Our 30 Seconds with Your 3PL Episode About The Importing & Exporting of API and Prescription Medications Handled by WDSrx

Summary

A global pharmaceutical company based in Germany required Active Pharmaceutical Ingredients (API) to be shipped to the United States for manufacturing. The finished goods were to be shipped back to Italy for distribution.

Challenge

sign indicating temperature data logger is on pallet

Data Loggers are used in all Cold-Chain Logistic orders to track the temperature along the route.

The pharmaceutical company could not ship product into the United States because they did not have proper U.S. customs certification.  Also, the raw materials required shipment within a refrigerated temperature range of 2-8 degrees Celsius.  The finished goods also were marked for refrigerated shipment on return to Italy.

Solution

Two Warehouse Managers receive inbound order.

Warehouse Manager Djyenson (left) and Supervisor Wayne (right), of the WDSrx Transportation Management team, receive a scheduled inbound order.

WDSrx supported this client by acting as the Importer of Record for the shipment into the United States.  This allowed the API to be transported from Italy while maintaining regulatory compliance.  The WDSrx transportation management team arranged door-to-door specialized refrigerated air cargo travel. Temperature and humidity were constantly monitored throughout the journey.  

Several documents were correctly completed in advance for FDA approval and expedited customs clearance by U.S. and Italian authorities. A commercial invoice and packing list for import and export, USDA statement, buyer’s EIN for import, and product Certificates of Analysis.  Additional details included pallet quantity and dimensions, number of master cartons and total pallet weight, FEI and DUNS numbers, HTS codes for each product, NDC and ANDA numbers.

Similar documentation was necessary for the export shipment and return to Italy.

WDSrx President meets with two members of the Quality Assurance Team

WDSrx President Adam Runsdorf meets with the Quality Assurance team regularly to overlook and approve important documentation.

“International air transport involves several parties that work together to manage the successful delivery of vital medications for patient treatment,” states WDSrx President Adam Runsdorf. “The WDSrx team helped assure import of raw materials and export of finished goods were completed on time and within compliance.”

Conclusion

The client imports and exports product regularly with a WDSrx commitment to increasing efficiency for every shipment.

Warehouse Supervisor fills truck with pallets using forklift.

Warehouse Supervisor Wayne is an integral part of the transportation management system by managing inbound and outbound orders at our headquarters facility.

Warehousing and fulfillment are important 3PL services.  At WDSrx these capabilities are enhanced with sophisticated freight forwarding solutions developed and implemented by an in-house transportation management team.  

Capabilities Utilized

Transportation Management – Pharmaceutical raw materials and finished goods must be transported with multiple handling and security safeguards to help assure successful pick-up and delivery.  High value contents are constantly monitored for temperature and location to maintain compliance throughout the journey.  Specialized freight forwarders are selected and managed by the WDSrx Transportation Management department to meet rigorous compliance standards.

Quality Assurance and Regulatory Compliance – Shipment of pharmaceutical products domestically and internationally requires accurate and current documentation to satisfy all parties including shipper, recipient, DEA, FDA, U.S. and international customs authorities.  The WDSrx Quality Assurance and Regulatory Compliance team verifies that all necessary details are completed in a timely manner to streamline shipment and delivery to final destination.

For further information contact Larry Hotz, (561) 998-3885 x304 or lhotz@wdsrx.com or you can visit our Youtube Channel

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.