Experic, a US contract development and manufacturing company, has received a manufacturing and import authorisation for investigational medicinal products, known as an MIA(IMP), and a GMP certificate from the Health Products Regulatory Authority (HPRA) for its clinical trial supply facility in Kilbeggan, Co Westmeath. The company announced the approval on 28 October 2026.
The licence lets the Kilbeggan site import, store, package, label, certify and distribute medicines used in clinical trials. That gives Experic, whose main facility is in Cranbury, New Jersey, a base inside the European Union to release trial supplies for studies run in EU countries. The company did not disclose the cost of the facility or the number of staff employed there.
- Approval: MIA(IMP) and a certificate of GMP compliance from the HPRA, following an inspection on 22 and 23 July 2026.
- Authorised activities: importation, storage, secondary packaging and labelling, Qualified Person (QP) certification and release, and distribution of investigational medicinal products.
- Storage: controlled ambient (15 to 25°C), refrigerated (2 to 8°C) and frozen (minus 25 to minus 15°C).
- Packaging: three dedicated secondary packaging and labelling rooms.
- Not disclosed: investment amount, floor area and job numbers.
1. What the HPRA approved
According to Experic's announcement, HPRA inspectors visited the Kilbeggan facility on 22 and 23 July 2026. They assessed whether the site met EU Good Manufacturing Practice (GMP), including its quality management system, standard operating procedures and the qualification of the building and equipment. The authorisation and GMP certificate followed.
Before the inspection, the company qualified the warehouse through temperature mapping, tested its refrigerated and frozen storage, and validated the heating, ventilation and air-conditioning system, environmental monitoring and the packaging and labelling suites. Those steps are standard for any site that will hold medicines for patients in trials, where a temperature excursion can make a whole batch unusable.
2. Why an EU licence matters for clinical trial supply
Under the EU Clinical Trials Regulation, investigational medicines made outside the European Union must be imported by a holder of a manufacturing and import authorisation, and each batch must be certified by an EU Qualified Person before it can be sent to trial sites. A US company that makes trial medicines in New Jersey therefore needs a licensed partner or its own licensed site in the EU to supply studies in Europe.
Experic says sponsors can now develop, manufacture and package their product at Cranbury, then move it to Kilbeggan for EU import, QP release and distribution. The company presents this as a way to cut the number of hand-offs between suppliers. The Kilbeggan site does not manufacture medicines itself; its licence covers secondary packaging, such as putting blister packs into labelled patient kits, and the release and distribution steps.
| Site | Role |
|---|---|
| Cranbury, New Jersey, US | Process and formulation development, clinical and commercial manufacturing, clinical packaging |
| Kilbeggan, Co Westmeath, Ireland | EU import, storage, secondary packaging and labelling, QP release, distribution of trial medicines |
3. About Experic
Experic was founded in 2018 and describes itself as a contract development and manufacturing organisation (CDMO) and clinical trial supply company. Its services run from analytical and formulation development to clinical and commercial manufacturing and clinical packaging and logistics. It specialises in hard-to-handle powders and inhaled products, including capsules and low-dose dry powder inhalers.
Chief executive Matthew Mollan called the HPRA authorisation an important milestone and said linking the Cranbury and Ireland operations would help trial sponsors simplify their supply chains. Philip Dunne, director of EU operations, credited the Irish team and said the approval lets Experic offer sponsors expanded clinical supply services from Kilbeggan.
4. What it means for Ireland's midlands
Most of Ireland's pharmaceutical manufacturing is clustered around Cork, Dublin, Limerick, Waterford and Galway. A licensed clinical supply site in Kilbeggan, on the M6 between Dublin and Galway, adds a small but specialist life-science operation to Westmeath. Westmeath already has medical technology and pharmaceutical employers, particularly around Athlone. Experic's own pitch to sponsors stresses the site's position between Dublin and Shannon and its access to international transport links.
Clinical trial supply is also a growing service in Ireland more broadly, as global sponsors look for EU bases to run studies under the Clinical Trials Regulation. Our Trials Performance Index tracks how clinical trial activity in Ireland compares with other European countries.
Frequently Asked Questions
What is an MIA(IMP)?
It is a manufacturing and import authorisation for investigational medicinal products, the medicines used in clinical trials. In Ireland, the HPRA grants it after an inspection shows the site follows EU Good Manufacturing Practice.
Does the Kilbeggan site make medicines?
No. Based on the activities Experic lists, the site imports, stores, packages and labels trial medicines, has them certified by a Qualified Person and distributes them. Manufacturing takes place elsewhere, for example at Experic's US facility.
How many jobs are at the Kilbeggan facility?
Experic has not disclosed staff numbers, the size of the facility or the amount invested.
Outlook
With its HPRA licence in place, Experic can start releasing trial supplies for European studies from Kilbeggan. The next signals to watch are whether the company names sponsors or studies using the site, and whether it publishes hiring or expansion plans for its Irish operation.
Sources
- Experic via Business Wire, Experic Receives MIA(IMP) Licence and GMP Certification for its Kilbeggan, Ireland Clinical Trial Supply Facility, 28 October 2026
- PharmaSource, Experic secures Irish GMP certification for clinical trial supply facility
- Health Products Regulatory Authority, hpra.ie
Cover image: Upper Main Street, Kilbeggan, Co Westmeath, Adlo1981, CC BY-SA 4.0, via Wikimedia Commons. The photo shows the town, not the Experic facility.
