Cell and Gene Therapy
With our in-depth knowledge and experience of Cell and Gene Therapy products, HiTech Health offer a range of services to help develop and supply life-changing treatments.
Process and Analytical Assay Development
Our experts can provide comprehensive solutions and strategies for process development, supply pre-clinical products and quality control assay development.
Qualified Persons Specialising in CGT
Ensuring you have the right person to release your product to the clinic is essential for success and HiTech Health can support you with this critical role.
Audits of CDMOs and Contract Testing Laboratories
Let us help you to perform an independent audit of your key manufacturer or testing laboratory to ensure you are receiving a quality service.
CGT Training
One of the biggest bottlenecks in the CGT space is finding the right people. HiTech Health offer a unique range of personalised training in the CGT space.
Supply Chain Assessment for CGT
Cell and gene therapies are distinctly different from traditional biopharma product and their supply chains require uniquely designed logistics solutions.
Regulatory Documentation Preparation
Our regulatory team will work with you through the latest guidelines and regulations specifically for cell and gene therapies.
Clients & Collaborators
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...
Cell and Gene Therapies: 3 Key Supply Considerations
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...
EMA Regulation of Cell and Gene Therapies (CGTs)
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...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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