Experic Secures Irish Authorization For Clinical Trial Supply Facility, Connecting U.S. And EU Operations
By Elizabeth Urbanek, Executive Editor
Experic’s clinical trial supply facility in Kilbeggan, Ireland, has received a Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP)) and Good Manufacturing Practice (GMP) certification from Ireland’s Health Products Regulatory Authority (HPRA), clearing the site to support key investigational medicinal product (IMP) activities for clinical trials.
Announced October 28, the authorization followed an HPRA inspection conducted July 22-23, 2026. The facility can now support IMP importation, storage, secondary packaging and labeling, Qualified Person (QP) certification and release, and distribution.
The authorization also connects the Irish operation with Experic’s drug product development, manufacturing and packaging capabilities in Cranbury, New Jersey. Sponsors can use the U.S. facility for those activities before transferring clinical trial materials to Ireland for EU importation, QP certification and release, and distribution.
What This Means For Clinical Supply
The authorization gives sponsors another option for organizing the movement of investigational products into the European Union. It also brings several activities that can determine when product becomes available for distribution into one clinical supply operation.
That matters because manufacturing a clinical batch is only one step in making investigational product available to trial sites. Importation, required quality documentation, QP certification and release, packaging, labeling and distribution all have to align with the study’s timeline and applicable regulatory requirements.
Experic’s Kilbeggan facility offers controlled ambient storage at 15°C to 25°C, refrigerated storage at 2°C to 8°C, and frozen storage at -25°C to -15°C. It also has dedicated secondary packaging and labeling rooms. These capabilities give sponsors options for handling products with different storage requirements, subject to each product’s specifications.
The U.S.-to-Ireland pathway could also simplify coordination for sponsors that choose to use Experic for both manufacturing-related activities and European clinical supply. However, using one provider across multiple stages does not eliminate the need to plan each handoff. Sponsors still need to establish responsibilities, confirm documentation requirements, coordinate shipment timing, and account for the time needed for importation and QP release before product can move into distribution.
The site’s authorization is a regulatory milestone, not a guarantee that every shipment will move faster. The practical effect will depend on the product, trial requirements, shipping route, documentation, and how the sponsor structures its supply network.
The Supply Question
When evaluating a European clinical supply partner, how will its importation, QP release, packaging and distribution capabilities fit into the timeline between manufacturing and product availability at clinical sites?
Related Clinical Supply Leader Editorials
- Clinical Trial Supply Challenges In Alzheimer's Trials
- The Operational Challenge Of Concurrent Shelf Life Extensions
About The Author
Elizabeth Urbanek is the Executive Editor of Clinical Supply Leader, where she works with clinical trial supply and logistics professionals to bring real-world perspectives and operational challenges to the field.
Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.
Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.