NanoEcho’s patented method includes both a medical device and a medicinal product, classifying the solution as a combination product. This means the final solution must comply with regulatory requirements in both pharma and MedTech. RegSmart has extensive experience in providing regulatory expertise for combination products.
Dr. Ulrika Axelsson, Clinical Director at NanoEcho, says:
“RegSmart has been very helpful for us in understanding the regulatory requirements for our innovative solution, especially for setting up the clinical studies for the combination product. Since classification and claims impact the regulatory route we need to follow, they also affect the cost and time to market. Therefore, RegSmart’s experience with combination products and their scientific understanding has been valuable in helping us find the optimal path forward.”
Mats Högberg, Director MedTech and IVD at RegSmart Life Science, adds:
“NanoEcho has a very exciting innovation that could significantly improve the treatment of rectal cancer for a large patient group. It is therefore important to quickly find the optimal regulatory route to avoid unnecessary delays. Our regulatory expertise in both pharma and MedTech gives us a unique ability to provide excellent regulatory guidance to companies with complex combination products. NanoEcho has also chosen to let our sister company, Clinical Trial Consultants (CTC), perform their clinical trials, which further simplifies the process due to our well-established collaboration with CTC.”