Our Ireland team is fully integrated within regenold, drawing on central expertise across CMC, clinical development, device regulation, and market access in 90+ countries via regulanet®.
— Ireland Services —
What We Do Locally
Our Ireland team delivers local regulatory operations, EU compliance infrastructure, and safety services from our Longford office. For the full methodology, workstreams, and deliverables behind each service, see the central regenold service pages.
Quality, GDP & GxP auditing
Quality, GDP, and compliance services operate from our Longford office, including batch certification under our MIA and IMP MIA, as well as outsourcing QPs and RPs to client licences. We also provide GxP auditing (GMP, GDP, and PV), supporting supplier qualification, internal audit programmes, and inspection readiness.
Pharmacovigilance
EU Qualified Person for Pharmacovigilance (QPPV) based in Ireland, with oversight of pharmacovigilance systems for EU marketing authorisation holders.
QP certification and EU market access for non-EU companies
For UK, US, Canadian, and other non-EU sponsors and MAHs, Ireland provides an English-speaking EU base for regulatory submissions, clinical trial sponsorship under the EU CTR, MAH infrastructure, and compliance roles. This includes the requirement for Qualified Person (QP) certification of both investigational and commercial medicinal products, which is mandatory for batch release into the EU supply chain.
Regulatory affairs
HPRA scientific advice, marketing authorisations (RMS/CMS roles, national, DCP/MRP), clinical trial applications (CTIS Part II, NREC ethics), and lifecycle management.
For our full methodology, workstreams, and deliverables across all services, see the central regenold service pages.
— Why regenold Ireland —
What Distinguishes Our Ireland Practice
EU batch release infrastructure (MIA & IMP MIA)
Our Ireland operation is built around our licensed infrastructure for batch certification. We hold both MIA and IMP MIA licences, with named Qualified Persons (QPs) responsible for certifying batches for commercial and investigational medicinal products. This certification is a mandatory requirement for products entering the EU supply chain, particularly for companies based outside the EU. We provide a ready-to-use EU batch release solution without the need to establish local infrastructure. We also recognize that our clients may wish to have their own infrastructure and we offer significant support in this regard.
EU market access for non-EU companies
For UK, US, Canadian, and other non-EU companies, Ireland provides an English-speaking EU base for market entry. From our Longford office, we support EU batch release, MAH infrastructure, and compliance roles required to place and maintain products on the EU market.
Pharmacovigilance infrastructure (EU QPPV in Ireland)
Our EU Qualified Persons for Pharmacovigilance (QPPVs) are based in Ireland, providing oversight of pharmacovigilance systems for EU marketing authorisation holders. We establish and maintain PV systems, act as the regulatory contact point, and ensure ongoing compliance with EU pharmacovigilance requirements.
HPRA experience and licence support
We work directly with the HPRA in maintaining our own MIA and IMP MIA licences and support clients in establishing their own Irish licences where required. This includes preparation for inspection, quality system setup, and ongoing compliance support.
Integrated UK and Ireland operations
Our UK and Ireland teams operate under one management structure. For products marketed in both regions, we coordinate MHRA and HPRA requirements, manage separate product information, and handle regulatory divergence without duplication.
Part of regenold
regenold was founded in 1994. Our Ireland team works closely with our colleagues in the UK, Germany, and Portugal, and draws on central expertise in CMC, clinical development, device regulation, and market access across 90+ countries via regulanet®.
Planning EU Market Entry, Setting Up Batch Release Infrastructure, or Need Support With HPRA Engagement and Compliance in Ireland?
Tell us about your product, your supply chain, and your target markets. We will outline the most practical route to EU market access, including QP certification requirements, batch release strategy (IMP and commercial), and the compliance roles needed.
We support both immediate needs through our own licensed infrastructure (MIA and IMP MIA) and longer-term setups, including establishing your own Irish licences, QMS, and inspection readiness. This includes QP declarations, GxP auditing (GMP, GDP, PV), and ongoing quality and compliance support.
Speak with an Expert— About Us —
Part of regenold
regenold Ireland is part of regenold, a regulatory affairs and development services company founded in 1994 and headquartered in Germany. regenold operates through offices in the UK, Portugal, Ireland, Switzerland, and Germany, enabling seamless cross-border collaboration in client projects.