- Experic has received a Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP)) and a Good Manufacturing Practice (GMP) certificate from Ireland’s Health Products Regulatory Authority (HPRA) for its clinical trial supply facility in Kilbeggan, Ireland.
- The authorization enables the facility to support investigational medicinal product importation, storage, secondary packaging and labeling, Qualified Person (QP) certification and release, and distribution for clinical trials across the European Union and other regions.
Experic, a contract development and manufacturing organization (CDMO) specializing in drug product development, manufacturing, and clinical supply services, has received a Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP)) and a Good Manufacturing Practice (GMP) certificate of compliance for its Clinical Trial Supply facility in Kilbeggan, Ireland. Ireland’s Health Products Regulatory Authority (HPRA) issued the authorizations following an inspection conducted July 22–23, 2026.
The authorization allows the facility to support the importation, storage, secondary packaging and labeling, Qualified Person (QP) certification and release, and distribution of investigational medicinal products (IMPs). These capabilities provide a regulatory basis for supporting clinical trials across all 27 European Union member states and other regions.
The Kilbeggan facility has 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 three dedicated secondary packaging and labeling rooms. Before the inspection, Experic completed a qualification program covering warehouse temperature mapping, storage conditions, heating, ventilation and air conditioning (HVAC), building and environmental monitoring systems, and packaging and labeling suites.
The authorization connects Experic’s European clinical supply operations with its drug product development, manufacturing, and packaging capabilities in Cranbury, New Jersey. Sponsors can transfer clinical trial materials from the U.S. facility to Kilbeggan for EU importation, QP certification and release, and distribution.
“Receiving HPRA authorization is an important milestone for Experic and a significant step forward in our strategy to provide more integrated, global clinical supply services.”
Matthew Mollan, Ph.D., Experic’s chief executive officer
Strategically located between Dublin and Shannon, the Kilbeggan facility provides access to international transportation networks. Experic said the newly authorized operations expand its ability to provide integrated clinical supply services to pharmaceutical and biotechnology sponsors, combining manufacturing with packaging, storage, and distribution support across the clinical development lifecycle.
