We are pleased to officially announce the launch of our new website, which reflects our expanding role as a leading professional service provider to pharmaceutical, biotechnology and medical device companies.
We are highlighting our services for Advanced Therapeutic Medicinal Products (ATMPs – which include cell and gene therapies). As our business continues to expand, the goal with this new website is to provide clear visibility on our services and the cross-functional experts we have at HiTech Health to support your company’s needs. The website now details the wide range of capabilities we offer surrounding cell and gene therapy services and at our process development laboratory in Galway, Ireland. This state-of-the-art facility is open for business and we can perform activities ranging from process and analytical development to personalised training in the lab.
Visitors can explore the many services we offer to a diverse range of clients ranging from early stage pre-clinical companies to large multinational corporations. Our focus is on Operations (CMC) from early product development through to product launch, HiTech Health has the experts that can enable a successful product registration and launch. Our team have led the development, manufacture, and supply of multiple products including cell and gene therapies to patients in several countries. We provide quality and compliance, QP and regulatory expertise, our team can be an extension of your internal resources. You can read about these services and much more on the new website. Going forward, we will continue to communicate regularly on the latest industry news and insights, as well as upcoming events where you can meet some of our team.
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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