Qualified Persons (QPs) Specialising in CGT
HiTech Health has QPs with expert knowledge in the CGT and ATMP field and can offer quality support for the successful release of your CGT product.
Cell & Gene Therapy QP Services
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Persons (QP). Due to the rapidly evolving ATMP landscape it is key to have up-to-date knowledge and expertise to successfully release product to clinical trials. HiTech Health’s QP team have the sought-after experience required to manage Quality aspects of product and process development.
HiTech Health Qualified Person (QP) batch release is in accordance with EU requirements (article 13 of EC Directive 2001/20/EC) on Investigational Medicinal Products (IMP) covering both sterile and non- sterile various dosage forms, including Advanced Therapeutic Medicinal Products. With HiTech Health’s clinical IMP MIA in place, CGT products can be imported and released to EU clinical trials in a matter of months.
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...
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