We can provide a full GMP manufacturing service for Advanced Therapeutic Medicinal Products (ATMPs) and offer quality and compliance services including QP release of products.
Our facilities are specifically designed to manufacture ATMPs where we can offer start to end manufacturing services. We can supply starting materials for ATMPS and offer manufacture, analytical and microbiological testing including rapid test methods and development of potency and other release assays. In addition we offer batch approval using our own Qualified Personnel (QP’s).
We can support our clients with material importation and shipping of quality samples as well as final product. This includes cold chain shipping of product.
We also support our clients with data preparation for use in their Investigational Medicinal Product Dossier (IMPD) regulatory filings.
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...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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