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.
Afortiori Development and HiTech Health Forge an Important Collaboration
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies. Galway, November 9, 2023 - Afortiori Development, a premier full-service Clinical Research...
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Stay Up To Date
Connect with us to receive the latest HiTech Health and industry updates.