GMP Manufacturing
We can provide a full GMP manufacturing service for Sterile Formulations and Advanced Therapies, including cell and gene therapies. Our team provide quality and compliance services including QP release of products.
GMP Manufacturing
Our GMP facilities (EU GMP Approved) are specifically designed to manufacture sterile formulations and advanced therapies, providing you with end-to-end development and manufacturing services. The range of services include sourcing and supply of starting materials for products, offering GMP manufacturing, QC analytical and microbiological testing including rapid safety test methods (Sterility, Endotoxin and Mycoplasma) and the development of potency and release assays. Designing and performing stability studies, which are critical for product development and filing, are also available at the site. In addition we offer batch approval using our own Qualified Personnel (QP’s) for both the EU and UK.
We can support our clients with material importation and shipping of products. This includes cryogenic, cold chain and ambient shipments.
We also support our clients with regulatory documentation preparation, such as the Investigational Medicinal Product Dossier (IMPD) and CT Protocol.
HiTech Health, University of Galway and Odyssey Validation Consultants awarded DTIF funding
The Disruptive Technologies Innovation Fund (DTIF) is a €500 million fund established under Ireland’s National Development Plan (NDP) in 2018. On Thursday 23rd November, Ireland’s Minister for Enterprise, Trade and Employment, Simon Coveney TD, Minister for Further...
Empowering Tomorrow’s Therapies: Hitech Health at Advanced Therapies Integrates 2023
Hitech Health is delighted to be attending Advanced Therapies Integrates in Stevenage, England on the 30th November. This event aims to drive the translation of cutting-edge research and disruptive innovation into the wide-spread adoption of Advanced Therapies,...
Afortiori Development and HiTech Health Forge an Important Collaboration
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies. Galway, November 9, 2023 - Afortiori Development, a premier full-service Clinical Research...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.