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.
New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
PMTC Spotlight – HiTech Health
HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight. HiTech Health is a full-service Contract Development and Manufacturing...
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.