HiTech Health | HiTech Health

We are an EMA-licensed Contract Development and Manufacturing Organization (CDMO) based in Ireland. Our GMP facility is modern, equipped with state-of-the-art technology, and located in close proximity to our Product Development laboratories. We hold Manufacturer’s/Importation Authorisations (MIAs) in both the EU (HPRA) and the UK (MHRA).

Our capabilities include:

• GMP manufacturing of advanced therapies, including cell and gene therapies
• Clinical-scale GMP sterile manufacturing and aseptic fill-finish services
• Quality control (QC) and microbiological analytical testing
• Clinical-scale packaging, labelling, storage (including cryo), and distribution (including import and export services)
• Process development support prior to GMP manufacturing

Our supporting CMC services include:

• EU and UK Qualified Person (QP) services to ensure quality, compliance, and the successful release of products to clinical trials or the market
• EU Responsible Person (RP) support across the pharmaceutical and cosmetic industries
• Expert supply chain management for companies engaged in both clinical and commercial projects
• EU and UK Importer of Record (IoR) and Exporter of Record (EoR)