RegSmart Life Science is a regulatory consultancy firm that will help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency and from small and big life science companies we facilitate your work by knowing ”what to do, when and how”. We provide fit for purpose advice and support in relation to European and US regulatory requirements, helping you to develop a regulatory plan as part of your overall project strategy. Our expertise is to analyse and interpret the guidance provided and decisions taken by regulatory agencies in EU and US and help answer the specific questions in your projects. We provide support from early research throughout your product life-cycle, always with the target product profile in mind.
Research in life science is developing at high speed leading to approval of important new products targeting patient for whom previous treatment options have been poor or non-existing. This positive development and scientific progress lead to new regulatory challenges and subsequent development of new legislation and guidelines. We will analyse the current regulatory environment and the available science to give specific guidance and support to help you reach your project goals. We combine scientific understanding with regulatory knowledge to minimize time to market.