Regsmart Life Science

RegSmart Life Science is a regulatory consultancy firm in pharma and medical device that will help you navigate in a complex and evolving regulatory landscape. 

We have extensive regulatory experience from regulatory agencies and industry building on strong scientific knowledge. We provide fit for purpose advice and support in relation to European and US regulatory requirements, helping you to develop a regulatory plan that addresses the regulatory needs. 

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. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the project.

We provide support from early research throughout your product life-cycle, always with the target