Regulatory Documentation Preparation
Working through the latest guidelines and regulations specifically for cell and gene therapies, our regulatory team can compile regulatory documentation and submissions for your product.
Clinical Trial Documentation
Creating an Investigational Medicinal Product Dossier (IMPD) can be very challenging and sometimes it is difficult to know where to start. At HiTech Health we have years of experience in creating IMPDs and regulatory documentation required for clinical trial submissions, and we can help you through this process and guide you on what is required. Our experts have submitted numerous regulatory submissions to many different regulators, including EU and FDA, and have an in-depth understanding of what is required.
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...
Cell and Gene at the Abbey 2021 – Galway, Ireland
From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this...
HiTech-Health awarded with government funding
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
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IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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