Innokas Medical participated in the project where the regulatory framework for NTNU’s new set of reagents were created.
NTNU Technology Transfer AS is a Norwegian-based company established in 2003, owned by the Norwegian University of Science and Technology (NTNU) and the Central Norway Regional Health Authority (Helse-Midt Norge). The deepest aim of the company is to lead the way from new ideas and innovations to reality by reducing risks and increasing the commercial value of research results.
One of the latest projects the researchers from NTNU have led was the development of a new test method for COVID-19. As a result, they created a set of reagents used for viral RNA extraction and PCR-based diagnostics.
“The reagents are approved for use in the major Norwegian Hospitals and also been sold internationally to various entities”, tells Tonje S. Steigedal (PhD), working as Business Developer at NTNU Technology Transfer.
When starting to move their patent-pending innovation to production and sales, NTNU team found the need for regulatory approval for their test method and started to seek regulatory consultancy guiding them in the process.
“In this Norwegian research Council-funded regulatory consultancy project, we asked Innokas to guide us on what our optimal regulatory strategy for these products should be. Additionally, we asked Innokas to make an outline of a detailed plan for how the regulatory process would look like for this product”, Steigedal tells.
“We chose Innokas Medical since the company seemed to have the exact competencies what we were looking for in-house”, she continues.
Steigedal sees Innokas as an excellent partner especially because of its very strong expertise and high-quality output in delivery. She tells that NTNU’s team has been very satisfied with the cooperation with Innokas team, and that the co-operation may continue also in the future.
“We needed specific guidance on the regulatory framework for a product, and often regulatory consultants seem to give a lot more information than you need and in very unstructured way. We really appreciated that Innokas were able to provide us clear and concrete advices to enable us to establish an efficient regulatory roadmap. This really added value for us”, Steigedal tells.
“The collaboration has been very good, and we are very happy with the delivery and might continue the collaboration at a later time-point”, she concludes.