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.
Qualified Persons (QPs) specialising in Cell and Gene Therapies
– 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.