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

Karin Westermark

Welcome to RegSmart, Karin Westermark, senior consultant medical devices


Welcome Karin Westermark! On February 1, you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years – first as Assessor and the last three years as Senior Assessor … Continue reading Welcome to RegSmart, Karin Westermark, senior consultant medical devices

Welcome to RegSmart, Sara Gallinetti, senior consultant, medical devices and biomaterials


Sara is an expert in clinical documentation under the new medical device regulation (MDR) and in biomaterials. Before joining RegSmart, Sara has held senior scientist positions in academia and industry for 7 years. Her main focus has been the transition from MDD to MDR compliance of clinical evaluation, post market surveillance, post market clinical follow-up (PMCF), … Continue reading Welcome to RegSmart, Sara Gallinetti, senior consultant, medical devices and biomaterials