Safeguarding a Clinical Trial Amid Regulatory and Logistical Constraints

How MRIGlobal Kept an Investigational Vaccine on Track

Preparing for a U.S. clinical trial can become especially complex when regulatory approvals and global logistics collide. A biopharmaceutical client faced this challenge when their investigational vaccine could not be imported into the United States due to the absence of an FDA-approved Investigational New Drug (IND) application.

At the same time, the European manufacturer required immediate removal of the vaccine from their facility. With no alternative storage options available in Europe, the client faced a serious risk to both product integrity and the clinical trial timeline.

MRIGlobal provided a comprehensive solution by leveraging expertise in logistics, regulatory compliance, and Foreign-Trade Zone (FTZ) operations. The team coordinated shipment of the vaccine from Europe to a US port of entry and then into MRIGlobal’s FTZ, ensuring the material was securely stored within US borders while adhering to FDA import regulations. In the FTZ, the vaccine was kept according to current good manufacturing practices set by the FDA. MRIGlobal’s on-site quality assurance group carefully reviewed and approved all documentation to guarantee full regulatory compliance.

Upon IND approval, MRIGlobal seamlessly transitioned the vaccine from the FTZ to a U.S. content warehouse. The clinical trial material was released within two days of U.S. entry, enabling the client to proceed without delay.

Facing your own regulatory or logistics challenges with clinical trial materials? Discover how integrated FTZ, regulatory support, and cGMP-compliant storage solutions can keep your program on track. Fill out the form below to download the full case study or contact us to learn how MRIGlobal can support you.