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 awarded with government funding
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
HiTech Health and Anthony Nolan announce collaboration
HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies. Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a...
HiTech Health, SextonBio and MedInstitute announce collaboration
HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems. Sexton Biotechnologies, in partnership with HiTech Health and Med...
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