Experic Secures HPRA Manufacturing and GMP Approvals for Kilbeggan Clinical Supply Facility in Ireland

Experic announced on October 28, 2026, that its Clinical Trial Supply facility in Kilbeggan, Ireland, has obtained a Manufacturer's/Importer's Authorisation for Investigational Medicinal Products, or MIA(IMP), along with a Good Manufacturing Practice (GMP) certificate of compliance issued by Ireland's Health Products Regulatory Authority (HPRA).

The clearance came after a successful inspection carried out on July 22–23, 2026.

Kilbeggan Facility Gains EU Clinical Trial Authorization

The authorisation allows the Kilbeggan site to handle importation, storage, secondary packaging and labeling, Qualified Person (QP) certification and release, and distribution of investigational medicinal products (IMPs).

According to the company, this creates the regulatory foundation to back clinical trials in every country of the European Union and in other regions worldwide.

Two-Step Inspection Covers Quality Systems and Qualification Work

The HPRA inspection assessed the facility's adherence to applicable EU GMP requirements, spanning quality management systems, operational procedures, and facility qualification.

Ahead of the review, Experic ran a wide-ranging qualification program that included warehouse temperature mapping, refrigerated and frozen storage, heating, ventilation and air conditioning (HVAC), building and environmental monitoring systems, and dedicated packaging and labeling suites.

Temperature-Controlled Storage Anchors Cold-Chain Handling

Kilbeggan 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, plus three dedicated secondary packaging and labeling rooms.

Experic says these capabilities underpin the handling and preparation of temperature-sensitive investigational products for clinical distribution.

The site sits between Dublin and Shannon, giving it access to international transportation networks and fitting into Experic's expanding global clinical supply infrastructure.

Chief Executive Points to Transatlantic Supply Chain Integration

Matthew Mollan, Ph.D., Experic's Chief Executive Officer, described the HPRA authorization as an important milestone for the company and a significant step in its strategy to deliver 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.

The link between the two sites lets sponsors use Experic's Cranbury, New Jersey, operation for drug product development, manufacturing, and packaging before moving clinical trial materials to Kilbeggan for EU importation, QP certification and release, and distribution.

EU Operations Head Highlights Expanded Service Range for Sponsors

Philip Dunne, Director of EU Operations at Experic, said the achievement reflects the dedication of the Ireland team and the extensive work to build 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."

Experic states that, with its newly authorized European operations, it continues to broaden its capacity to support pharmaceutical and biotechnology sponsors across the clinical development lifecycle, pairing specialized manufacturing expertise with integrated packaging, storage, and distribution services to help advance therapies toward patients.

Company Background

Founded in 2018, Experic is a contract development and manufacturing organization (CDMO) and clinical trial supply services company.

Its service range covers process development, analytical and formulation development, clinical and commercial manufacturing, and clinical packaging and logistics. The company specializes in challenging powders and inhalation products, including capsules and low-dose dry powder inhalation therapies.

Experic operates from a Class A cGMP facility in Cranbury, New Jersey, and its Clinical Supply Center facility in Kilbeggan, Ireland, and manages the global delivery of products, including for expedited projects.