Ireland Europe
FDF / DRUG PRODUCTS BIOLOGICS COSMETICS in Europe
Contract Development & Manufacturing Organisation
About the plant
HiTech Health 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. HiTech Health holds Manufacturer’s/Importation Authorisations (MIAs) in both the EU (HPRA) and the UK (MHRA).
HiTech Health’s 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)
Certifications
- EMA (EU GMP)
Activity
- Cell therapy derivatives / Secretomes, ATMP (Advanced Therapies), Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Powder, Bottles, Tubes, Sprays, Bulk, Sachets, Stick packs, Ampoules, Oral solutions, Oral suspensions, Oral emulsions, Terminal sterilization, Fill&Finish, Bottles, Dropper bottles, Tubes, Semisolid forms, Liquid forms, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, BIOLOGICS, COSMETICS, Skin products, Hair and scalp care products, Products for nails and cuticles, Oral hygiene products, Skin care, Skin cleansing, Make-up, Sun protection and self-tanning, Other skin care products, Hair and scalp care and cleansing, Hair coloring, Hair styling, Other hair and scalp care products, Other nail and cuticle products, Other oral hygiene products, Solid or compact powder, Loose powder, Cream / paste, Liquid, Others, Foam manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Human
- Toxicity (OEB classification): N/A
- DEA: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China)
Batch Size / Reactor
- Small, Medium, Batch, Fed-batch, Perfusion, 1 - 100 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, GDP, CMC regulatory support, IMPD (Investigational Medicinal Product Dossier) submission support, DMF (Drug Master File) preparation and submission, Samples manufacturing
