Case Studies Archive - Alacrita

CMC and regulatory due diligence for a medical imaging agent

Written by Cort | Aug 6, 2024 2:24:51 PM

Challenge

One of the leading medical imaging companies worldwide approached Alacrita to assess an opportunity to acquire the manufacturing and distribution rights to an important imaging agent used in various surgical procedures. The product had lost patent protection some time before, but the vendor asserted that there were significant defensive moats associated with CMC issues and regulatory considerations. Our client asked Alacrita to verify the significance of these apparent defenses, to estimate the revenue potential of the imaging agent and to assess the associated risks. 

Solution

A three person core team comprising Alacrita's medtech Partner, a CMC specialist and a senior regulatory affairs consulted undertook this assignment. They assessed the information made available by the vendors, and by reference to the results of secondary research and their pre-existing expertise formulated a report that addressed the client's concerns.


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