RegSmart Life Science

RegSmart Life Science AB is a regulatory consultancy firm that can help you navigate in a complex and evolving regulatory landscape. With our combined regulatory experience from senior positions at the Swedish MPA (Läkemedelsverket) and from small and big life science companies we can facilitate your work by knowing what to do, when and how.

We advise and support in relation to European and US regulatory requirements, can help you develop a regulatory plan as part of your overall project strategy. Our expertise is to analyze and interpret the guidance provided and decisions taken by regulatory agencies in both EU and US to help answer specific questions in your projects. We provide support from early research throughout your product’s life-cycle, always with the final product in mind.