Qualified Persons (QPs)
HiTech Health has Qualified Persons with expert knowledge in the Cell and Gene Therapy (CGT) and Advanced Therapy Medicinal Products (ATMP) field. We can offer Quality support for the successful release of your CGT product.
Cell & Gene Therapy Qualified Person Services
– EU & UK QP Batch Importation and Release
HiTech Health’s Qualified Person (QP) team have extensive experience in releasing clinical and commercial products in both the EU and the UK.
- Cell and gene therapies, biologics, sterile products, non-sterile products including small molecules.
- Quality support including audits and QP Declarations.
- Regulatory documentation support.
- Importation services to support batch approvals into and out of the EU and the UK.
- Demonstrated experience in release of ATMPs including cell and gene therapies which are often released on the day of patient treatment.
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...
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.