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.
2024 ATMP Review
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Temperature Controlled Transportation of Medicinal Products
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.