Quality & Compliance

MIA and WDA licensing, GxP compliance, Responsible Persons services, Qualified Person services, and inspection preparation for HPRA-regulated operations in Ireland. We hold our own Irish MIA & IMP-MIA licences with named QPs.

For QP batch certification services, see QP Services. For Responsible Person services, see RP Services. For GxP auditing, see GxP Auditing. For our full quality services, see the central Quality & Compliance page.

What This Page Covers

This page is for companies that already have their Irish licences in place and need ongoing quality and compliance support. If you are setting up in Ireland for the first time and need a MIA or WDA application, RP appointment, or QP certification, see our EU Market Entry page.

Health Authority Inspection Readiness

Ensuring your organization is fully prepared for regulatory inspections is critical to maintaining compliance and protecting product quality and patient safety. Our Inspection Readiness Services provide expert guidance and practical support to help you confidently navigate health authority inspections.

Regulatory inspections assess manufacturing and distribution sites against Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), or other relevant standards. They may be routine, risk-based, or triggered by events such as licence applications, significant variations, or reported quality issues. Findings can result in observations, licence conditions, supply disruptions, or regulatory action.

What we do:
  • Conduct gap analyses against GMP, GDP, and regulatory inspection expectations
  • Run mock inspections replicating the scope and approach of health authority inspections
  • Review and strengthen documentation, SOPs, and quality system records
  • Prepare key personnel for inspector questioning
  • Support response compilation and close out of any remedial actions.

GMP Compliance & MIA and WDA Maintenance

Maintaining an Irish Manufacturer’s/Importer’s Authorisation (MIA) requires continuous GMP compliance. Maintaining an Irish WDA equally requires continuous GDP compliance. Effective MIA and WDA maintenance ensures that your quality systems, documentation and authorised activities remain current, controlled and aligned with regulatory expectations.

Regulatory authorities expect that licence holders maintain accurate, up-to-date quality documentation (including site master files), manage changes through established variation/change control processes, keep key personnel and responsible roles documented, and close out inspection findings with effective corrective actions.

What we do:
  • Support MIA and WDA variation applications for changes to licensed activities, personnel, or contract sites
  • Maintain and review site master files and other core regulatory documentation to reflect current operations and compliance status.
  • Manage GMP documentation, deviation investigations, and change control
  • Support GMP inspection readiness and post-inspection CAPA closure

Need Compliance Support or Preparing for an HPRA Inspection?

Tell us what you need and we will outline the route.

Contact Us