Our motto is Regulatory Relevant & Scientifically Sound.
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. 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.
RegSmart was founded 2019. In 2021, we have strengthened our team with pharmacovigilance to cover the needs post-approvals. In 2022, we added clinical development plans to our services. Our vision is to create a company building on extensive regulatory experience and on firm scientific knowledge. We believe that progress in research and development comes from teamwork and we are committed to bring the regulatory aspects to the table. By including the regulatory and clinical aspects early on in the project, the path to market access can be influenced and time to market minimized. All projects are different and there are rarely any standard solutions to the challenges in product development. 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 individual project. We will help you look into the future and predict in what direction the regulation is heading.
Center for Translational Research AB (CTR) is a holding company founded in 2016. The company partly owns RegSmart Life Science AB, CTC Clinical Trial Consultants AB, Lablytica Life Science, Toxicology Knowledge Team Sweden, Regfile, MetaSafe and QAlliance.