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.
Why Ireland for Manufacturing Cell and Gene Therapies?
Ireland has a strong track record of attracting major investment from the largest pharma companies in the world. The foundation of Ireland’s life sciences industry has been the small-molecule sector and has since developed expertise in biologics manufacturing. Ireland...
Cell and Gene Therapy Manufacturing
HiTech Health are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...
2024 ATMP Review
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
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.