Biomedical Courier Services

CASE STUDIES

STUDIES

Lab Direct Satisfied USDA Requirements to Enable Timely Transcontinental Transportation of Active Pharmaceutical Agent

Challenge

An Australian client was seeking a lawful way to ship an Active Pharmaceutical Agent (API) – as listed by the United States Agricultural Department (USDA) – CDC from Australia to the United States.
The challenge faced was correctly identifying the germanium compound so as not to jeopardise client’s chance to continue supplying drug products and substances to U.S.A. As the substance was required to meet the specifications of a manufacturing project, an effective solution enabling successful and quick intercontinental delivery was required.

Solution

Lab Direct tackled the primary problem of correct substance classification as per USDA guideline 1105 for chemically synthesized materials, including biochemicals not containing or derived from animal products. As per USDA’s procedures for import under Guideline 1105, Lab Direct Global drafted a letter identifying the material, confirming it is unfit for human consumption and providing an explanation for its intended use. Shipment of the substance was also seamlessly coordinated to ensure the fastest delivery times.

  • Met USDA’s and FDA’s requirements to go through customs quickly and reach the manufacturer in a timely manner
  • Helped client establish trust with American partner and begin a positive track record with customs officials
  • Documented the solution to employ for future projects of the same or similar nature

Lab Direct Achieved the Fastest Possible Delivery Times for a High-Value Temperature Sensitive Virus from Australia to New Zealand with 24-hours

Challenge

Lab Direct was contracted to coordinate the time-sensitive delivery of 450 vials of a commercial, high-value freeze dried virus from Australia to New Zealand. The challenge was to maintain a temperature of -80°C during transportation and deliver the shipment within the stated 24-hour deadline timeframe.

Solution

As Lab Direct is an experienced and a well-resourced logistics provider of biologically sensitive matter, we were able to correctly configure the required temperature and ensure a consistent, cold chain environment prior to collection. Our logistics allowed us to safely move shipment with a fast turnaround.
We were prepared for contingencies in the event of an unforeseen delay, having a team of experts and our service partner on standby to troubleshoot issues and replenish the dry ice. We established a communication SOP between our Australian office and our team on the ground in New Zealand to enable near real-time notifications and awareness of the shipment’s movement to ensure clarity about arrival times.
As safety, sample integrity and turnaround rather than expense were the focus of this project for the client, we were able to move forward flexibly and match the fastest possible delivery times.

  • Met short turnaround times
  • Maintained product integrity
  • Smooth communications between Australia-New Zealand teams

Lab Direct Coordinated the Transport of Blood constantly maintained at 4°C from Sao Paulo Brazil to Australia

Challenge

The initial project involved arranging for a packaging kit to be sent from Australia to Brazil for purposes of packing and transporting blood. Custom regulations are extremely stringent in Brazil and require paperwork to be perfect. Problems of excessive administration and bureaucracy also exist. It is common for goods entering and leaving the country to be held at up at the border as a result of complex procedures. Lab Direct Global and the client faced the task of overcoming customs challenges to achieve results without much delay.

Solution

Lab Direct leveraged its experience and network in three distinct ways to not only meet the initial brief of providing the packaging kit but also arranging for the sample to be transported from Brazil to Australia:

  1. Addressed import/export regulatory requirements, meeting pre-import guidelines and successfully obtaining pre-clearance approvals
  1. Implemented a packaging and coolant strategy to determine the suitability and compatibility of packaging using stability data
  1. Coordinated with a third-party to book the first direct flight via Sydney and the next flight out to Melbourne the following morning
  • Completed the project in just in over 2 days
  • Coordinated the glitch-free transport of a critical sample over a distance spanning 14,000 km
  • Client was able to meet the special requirement after several failed attempts previously