Matthias Rother and Rolf Karlsten

RegSmart adds clinical development plans as service


During September 2022, RegSmart starts a collaboration with Matthias Rother and Rolf Karlsten as sub-consultants to RegSmart aiming at offering clinical development plans within pharma and medical device. “The clinical and regulatory plans are closely integrated, and central parts of the overall development plan” explains Marie Gårdmark, CEO at RegSmart. “We have seen that small … Continue reading RegSmart adds clinical development plans as service

IVD manufacturer – use the progressive roll-out of IVDR in a smart way


The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation. … Continue reading IVD manufacturer – use the progressive roll-out of IVDR in a smart way

Welcome to RegSmart, Anders Juréus, senior consultant drug development


Welcome Anders Juréus! On April 19 you joined our team as senior consultant drug development. What is your background, prior to joining RegSmart? I have extensive and broad drug development experiences from the pharmaceutical industry as well as academia and regulatory authorities. Most recently, I come from the Swedish Medical Products Agency were I held … Continue reading Welcome to RegSmart, Anders Juréus, senior consultant drug development

RegFile is now in operation


Earlier this year, Center for Translational Research (CTR) revealed the establishment of a new regulatory company, RegFile AB, complementing RegSmart in its services. RegFile, led by CEO Maria Santesson, is now ready to start providing regulatory affairs support to customers. Maria Santesson is one of the founders of RegFile and will start as the new … Continue reading RegFile is now in operation

Anna Wannberg

Welcome to RegSmart, Anna Wannberg, senior consultant medical devices


Welcome Anna Wannberg! On March 28 you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Well, I have a long regulatory background, for the last ten years at the Swedish Medical Products Agency, MPA. My main focus there was regulatory questions, such as borderline and classification, but also … Continue reading Welcome to RegSmart, Anna Wannberg, senior consultant medical devices