LICENSALE analyzes compliance data and implements machine learning to manage the medical and IVD device registration process, across 140 global markets

Thus, the more one uses the offering, the more efficient and cost-effective their market approval processes will become. The offering also provides legal, commercial, and operational benefits beyond providing an actionable birds-eye view of product registrations. Users get to retain ownership of licenses and confidentiality of IP, and the system supports RnD by providing accurate compliance and sales advancement information that fosters better alignment between regulatory and commercial strategies.

Benjamin cites the case of a client called OraSure, an American manufacturer of in-vitro diagnostics products, who had developed a self-test HIV diagnostic kit which is currently sold in the US. With the support of the prestigious Bill & Melinda Gates Foundation, the client intended to bring that product into third world country markets, mostly in Africa. However, to do so, they had to make changes in the configurations of the product so that it could be more affordable in those countries. Arazy Group is in the process of carrying this product from the U.S and bringing it to physicians and patients in about 40 countries around the world. This is a big win in terms of the humanitarian aspect and in addition, to the pain points associated with handling multiple registrations of the same product in multiple countries. The complexities with countries that had established regulations, or others with none, were tricky to maneuver, but with Arazy Group, the company was able to work directly with governments, to establish routes to bring the kit to market.

With the kind of global presence that Arazy Group and LICENSALE have, they envision to add more clients to their fold, while sharpening the edge of their offering. The company is going to release their next-generation LICENSALE2.0, which would bring a modern, user-friendly interface, for an even more simplified and automated regulatory approval process, advanced data analysis, and reporting, packaged in this state of the art, next-generation Global Medtech Registration Management System. With a lot of statistical information and data, V2.0 will allow clients to plan their products’ extension globally and the management of their overall activities in various markets.