About Us & Our Team
Want an experienced team to help with product development, manufacture, launch and supply?
HiTech Health has the knowledge and expertise to help with product development and ensure all CMC related operational activities are completed on time. We can save you time and money when compared to building this expertise internally.
Our cell and gene therapy expertise extends beyond services to include process and analytical development at our state-of-the-art laboratory.
Looking for an experienced team that can help with all aspects of CMC product development?
HiTech health has the in-house experts that can help from pre-clinical through a successful product registration and launch. We can help with product development strategy creation right through to day-to-day project management.
Our team have led the development, manufacture and supply of multiple products including cell and gene therapies for clinical trials and also the supply of approved medicines to patients.
Partner of Choice
HiTech Health can provide a team to enable all the activities including product importation, QP approval and management of supply chain through to your distributor.
We can provide experts who know what needs to be done and can help you to meet project goals and timelines. This approach can save you time and money.
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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