Experic Receives MIA(IMP) Licence and GMP Certification for its Kilbeggan, Ireland Clinical Trial Supply Facility

CRANBURY, N.J.--(BUSINESS WIRE)--Experic, a contract development and manufacturing organization (CDMO) specializing in drug product development, manufacturing, and clinical supply services, today 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), following a successful inspection conducted July 22–23, 2026.

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 HPRA inspection evaluated the facility's compliance with applicable EU GMP requirements, including its quality management systems, operational procedures, and facility qualification. In preparation, Experic completed an extensive qualification program encompassing warehouse temperature mapping, refrigerated and frozen storage, heating, ventilation and air conditioning (HVAC), building and environmental monitoring systems, and dedicated packaging and labeling suites.

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.

About Experic

Experic is a contract development and manufacturing organization (CDMO) and clinical trial supply services company dedicated to revolutionizing pharmaceutical development, manufacturing, and clinical trial supply. 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, our expertise encompasses capsules, and low-dose dry powder inhalation therapies. Operating from our state-of-the-art, Class A cGMP facility in Cranbury, New Jersey, as well as our Clinical Supply Center facility in Kilbeggan, Ireland, we manage the global delivery of high-quality products, even for expedited projects. Our team of industry leaders brings decades of experience in pharmaceutical product development and clinical trial supplies, ensuring strategic vision and execution for every project. For more information, please visit www.expericservices.com.