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.
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...
Five Key Considerations When Selecting a Cell and Gene Therapy CDMO
Many Cell and Gene Therapy (CGT) companies outsource product development and manufacturing activities to a Contract Development and Manufacturing Organisation (CDMO). It is critical to ensure that an informed decision is made when selecting a CDMO to prevent future...
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...
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Get in touch anytime – we are always available to discuss your upcoming projects.