Qualified Persons (QPs)
HiTech Health have an in-house team of Qualified Persons (QPs) with expert knowledge of advanced therapies including cell and gene therapies. We can provide batch importation, batch release and quality oversight of your advanced therapy. HiTech Health holds Manufacturer’s / Importer’s Authorisations (MIAs) in both the EU and UK.
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 advanced therapies including cell and gene therapies which are often released within a matter of days of patient treatment.
- GMP / GDP compliance support.