GMP Manufacturing
We can provide a full GMP manufacturing service for Sterile Formulations and Advanced Therapies, including cell and gene therapies. Our team provide quality and compliance services including QP release of products.
GMP Manufacturing
Our GMP facilities (EU GMP Approved) are specifically designed to manufacture sterile formulations and advanced therapies, providing you with end-to-end development and manufacturing services. The range of services include sourcing and supply of starting materials for products, offering GMP manufacturing, QC analytical and microbiological testing including rapid safety test methods (Sterility, Endotoxin and Mycoplasma) and the development of potency and release assays. Designing and performing stability studies, which are critical for product development and filing, are also available at the site. In addition we offer batch approval using our own Qualified Personnel (QP’s) for both the EU and UK.
We can support our clients with material importation and shipping of products. This includes cryogenic, cold chain and ambient shipments.
We also support our clients with regulatory documentation preparation, such as the Investigational Medicinal Product Dossier (IMPD) and CT Protocol.
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...
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.