Experic, a contract development and manufacturing organization (CDMO) specializing in drug product development, manufacturing, and clinical supply services, has announced that its Clinical Trial Supply (CTS) facility in Kilbeggan, Ireland has received a Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products MIA(IMP) and a Good Manufacturing Practice (GMP) certificate of compliance from Ireland’s Health Products Regulatory Authority (HPRA).
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.
The authorization marks a significant milestone in Experic’s European expansion, enabling the Kilbeggan 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 foundation for Experic to support clinical trials across all countries in the European Union, as well as other regions around the world.
“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,” said Matthew Mollan, Ph.D., Experic’s Chief Executive Officer. “By connecting our drug product development, manufacturing, and packaging capabilities in Cranbury, New Jersey with our newly authorized clinical supply operations in Ireland, we can help customers streamline their supply chains, reduce the complexity of working across multiple service providers, and move their clinical programs forward more efficiently.”
The Kilbeggan facility features controlled ambient storage (15°C to 25°C), refrigerated storage (2°C to 8°C), frozen storage (-25°C to -15°C), and three dedicated secondary packaging and labeling rooms. These capabilities support the handling and preparation of temperature-sensitive investigational products for clinical distribution.
“This achievement reflects the dedication of our Ireland team and the extensive work undertaken to establish a facility and quality systems that meet European regulatory standards,” said Philip Dunne, Director of EU Operations at Experic. “With our MIA(IMP) authorization and GMP certification in place, we can now offer sponsors an expanded range of clinical supply services from Kilbeggan, including importation, secondary packaging, labeling, and QP certification and release. This positions us to support the increasingly complex requirements of clinical trials conducted across the 27 countries in the European Union.”
The authorization also strengthens the connection between Experic’s U.S. and European operations. Sponsors can leverage Experic’s Cranbury facility for drug product development, manufacturing, and packaging before transferring clinical trial materials to Kilbeggan for EU importation, QP certification and release, and distribution.
Strategically located between Dublin and Shannon, the Kilbeggan facility provides access to international transportation networks and supports Experic’s growing global clinical supply infrastructure.
With its newly authorized European operations, Experic continues to expand its ability to support pharmaceutical and biotechnology sponsors across the clinical development lifecycle, combining specialized manufacturing expertise with integrated packaging, storage, and distribution services to help advance therapies toward patients.
Established in 2018, Experic offers a comprehensive suite of services, including process development, analytical and formulation development, clinical and commercial manufacturing, and clinical packaging and logistics. Specializing in challenging powders and inhalation products, Experic’s expertise encompasses capsules, and low-dose dry powder inhalation therapies.
