Having successfully partnered in the launch of 15 significant orphan and niche drug products into the EU market over the last 3 years, Almac have witnessed a steady increase in the number of U.S. companies taking advantage of European Market Opportunities and expect this trend to increase.
This article by Michael Rooney, Senior Business Support Manager at Almac, explores the European marketplace and how it presents a variety of challenges, from complex regulatory frameworks to numerous official working languages and varying country supply chain conditions.
Having supported a range of US clients in their EU launch from as far as 24 months before submission of their MAA to those with shorter time frames, post submission, Michael explains that it’s never too early to start to think about your pharmaceutical product launch. To gain more insight into the EU market, submit your details below.