US Market Matters for Life Sciences Companies
Many Life Sciences companies in Northern Ireland have successfully expanded to the U.S. market, and many more are poised to do so in the next several years. These companies must navigate a regulatory pathway to get (and stay) in the market, and understand the basic policies, sometimes unwritten, that drive decision-making at the U.S. Food and Drug Administration (FDA).
Companies also must determine the best method by which to access the U.S. market, minimize tax complications, and insulate the Northern Ireland parent from U.S. liability. Michael Burke and Alan Minsk, Arnall Golden Gregory, LLP will present a workshop on behalf of Invest NI to provide life sciences companies in Northern Ireland with what they need to know now about expanding to the U.S. market. The workshop will cover:
- Interacting with the FDA;
- Addressing advertising and promotional concerns for life sciences products;
- Distance (direct sales, distributors, and agents) expansion versus setting up a U.S. affiliate company;
- Basic U.S. regulatory compliance strategies for medical devices, pharmaceuticals, cosmetics, healthcare IT, and wellness devices;
- Tax considerations related to U.S. expansion; and
- Insulating the Northern Ireland parent from U.S. operational liability and risk.
|12:00||Lunch & networking|
|13:30||Q & A|
A limited number of appointments will be available for 1:1 meetings with Mike and Alan for Invest NI customers who have specific queries or are interested in the market. To book an appointment select a time from the dropdown menu when registering.