The client is a German-based IVD manufacturing company with global presence and has a portfolio of wide range of oncology focused clinical diagnostics. In the process of evaluating various service providers, the client approached Freyr for initial Regulatory Intelligence (RI) support to define their market strategy, followed by Regulatory support on IVD registration and Legal Representative Services for all the countries in scope. However, the absence of single local point of contact for each country-specific regulation was challenging for the client. In addition, it was more challenging for Freyr to meet the registration timelines and requirements and compile the documents for more than 200 medical devices and their accessories, as per the country-specific Health Authority regulations.
How did Freyr deal with this project in a phase-wise approach? How was the client beneficial with the end-to-end Regulatory services catered by Freyr? Discover with this proven case.