Qualified Persons (QPs) Specialising in CGT

HiTech Health has QPs with expert knowledge in the CGT and ATMP field and can offer quality support for the successful release of your CGT product.

Cell & Gene Therapy QP Services

 

In Europe, no batch of medicinal product can be released prior to certification by a Qualified Persons (QP). Due to the rapidly evolving ATMP landscape it is key to have up-to-date knowledge and expertise to successfully release product to clinical trials. HiTech Health’s QP team have the sought-after experience required to manage Quality aspects of product and process development.

HiTech Health Qualified Person (QP) batch release is in accordance with EU requirements (article 13 of EC Directive 2001/20/EC) on Investigational Medicinal Products (IMP) covering both sterile and non- sterile various dosage forms, including Advanced Therapeutic Medicinal Products. With HiTech Health’s clinical IMP MIA in place, CGT products can be imported and released to EU clinical trials in a matter of months.

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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