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 and 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 biopharmaceutical products in both the EU and the UK for both clinical and commercial products.
- Cell & 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 ATMP’s including cell and gene therapies which are often released on the day of patient treatment.
GMP Manufacturer for Sterile Formulations including Cell and Gene Therapies
Ireland, 12th Feb 2024: Hitech Health, a Contract Development and Manufacturing Organisation (CDMO) for advanced therapies, has opened an additional facility in County Galway, Ireland. The new high-specification manufacturing centre is equipped with state-of-the-art...
2023 ATMP Review
The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...
Cell Therapies: HiTech Health & VascVersa Partnership
HiTech Health is thrilled to announce its partnership with VascVersa, a trailblazer in regenerative medicine focusing on pioneering cell therapies that significantly enhance vascular regeneration and repair. Originating from Queen's University Belfast, VascVersa is a...
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.