Experic, a contract development and manufacturing organization (CDMO) specializing in drug product development, manufacturing, and clinical supply services, announced on October 28, 2026, that its Clinical Trial Supply (CTS) facility in Kilbeggan, Ireland, has received a Manufacturer's/Importer's Authorisation for Investigational Medicinal Products, known as MIA(IMP).

Additionally, the facility has obtained a Good Manufacturing Practice (GMP) certificate of compliance from Ireland's Health Products Regulatory Authority (HPRA). The authorization follows a successful inspection conducted July 22–23, 2026.

Experic Secures EU Authorization for Kilbeggan Facility

According to the company, the authorization marks an important turning point in Experic's European expansion.

It enables 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.

Leadership Comments on the Milestone

Matthew Mollan, Ph.D., Experic's Chief Executive Officer, said receiving HPRA authorization is an important milestone for Experic and a significant step forward in the company's strategy to provide more integrated, global clinical supply services.

"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," Mollan said.

Philip Dunne, Director of EU Operations at Experic, said the achievement reflects the dedication of the company's Ireland team and the extensive work undertaken to establish a facility and quality systems that meet European regulatory standards.

"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," Dunne said. "This positions us to support the increasingly complex requirements of clinical trials conducted across the 27 countries in the European Union."

Inspection Scope and Preparatory Qualification Program

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 for the inspection, 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.

Facility Storage and Packaging Capabilities

The Kilbeggan facility features controlled ambient storage at temperatures of 15°C to 25°C, refrigerated storage at 2°C to 8°C, and frozen storage at -25°C to -15°C, along with three dedicated secondary packaging and labeling rooms.

According to the company, these capabilities support the handling and preparation of temperature-sensitive investigational products for clinical distribution.

The facility is strategically located between Dublin and Shannon, providing access to international transportation networks and supporting Experic's growing global clinical supply infrastructure.

Linking U.S. and European Operations

The authorization also strengthens the connection between Experic's U.S. and European operations.

Sponsors can leverage Experic's Cranbury, New Jersey, facility for drug product development, manufacturing, and packaging before transferring clinical trial materials to Kilbeggan for EU importation, QP certification and release, and distribution.

With its newly authorized European operations, Experic states that it 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 CDMO and clinical trial supply services company established in 2018. The company offers a suite of services, including process development, analytical and formulation development, clinical and commercial manufacturing, and clinical packaging and logistics.

Experic specializes in challenging powders and inhalation products, with expertise encompassing capsules and low-dose dry powder inhalation therapies. The company operates from a Class A cGMP facility in Cranbury, New Jersey, as well as its Clinical Supply Center facility in Kilbeggan, Ireland, and manages the global delivery of products, including for expedited projects.

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