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.

2023 ATMP Review

The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.