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.
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...
Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as 'a medical model using the characterisation of...
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
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