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.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
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.