Case Study
Open Market: Creating a Clearing for Commercialization
Open Market: Creating a Clearing for Commercialization Challenge The patent life of a crop protection active ingredient (AI) had expired, giving an international company access to a generic molecule manufactured in China. Among the challenges facing the organization, however, was the potential cost of re-approval of the active ingredient in Europe. Could there be a profitable payoff in pursuing product registrations—before re- approval of the AI—in order to tap into new market opportunities? More importantly, could the company, with its limited resources, lack of in- house regulatory expertise and narrow window of opportunity, navigate a myriad of mandatory compliance and regulatory requirements in time? Solution At the outset, it was a matter of risk versus reward when the company asked B