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.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
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Get in touch anytime – we are always available to discuss your upcoming projects.