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The regulatory pathway and quality frameworks for combination products are not only complicated but as well differ per region. When organizations foster combination products, approval for regulatory for both the device and pharmaceutical components should be obtained and the quality frameworks should support either of them.
Graywolf Research Group carry expertise in the medical device you want for combination products. The regulatory cycle for combination products as a rule begins with an FDA pre-submission or regulatory plan for EU MDR compliance.
Starting with the region-wise assigning, Graywolf Research Group subject matter individuals will assist you with defining the regulatory pathway to offer your product for sale in the market in the most proficient way based on the claims being made.
The knowledge, experience, and information at Graywolf Research Group allow us to expertly help you with your combination product regulatory submissions, including FDA 510(k), De Novo, RFD, EUA, PMA, IDE, and breakthrough in the U.S., and navigation of article 117 in the EU.
