Sophie Bertilsson, Senior Consultant at RegSmart

Welcome to RegSmart, Sophie Bertilsson, senior consultant, CMC and pharmaceutical development


Sophie is an expert on chemical/pharmaceutical aspects of drug development. Most recently, Sophie comes from the Swedish Medical Products Agency (MPA), where she spent four years as a chemistry and pharmaceutical assessor. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations. She has over 15 … Continue reading Welcome to RegSmart, Sophie Bertilsson, senior consultant, CMC and pharmaceutical development

Welcome to RegSmart, Brita Liljestrand, senior consultant in medical devices!


Brita is an expert in medical device regulations (MDD/MDR) and has a long experience of use and maintenance of medical devices in the health care environment. She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for the last 12 years. Brita has worked with inspections of manufacturers, and … Continue reading Welcome to RegSmart, Brita Liljestrand, senior consultant in medical devices!

Karin Meyer, ny VD för CTR

Karin Meyer blir ny VD för Center for Translational Research Sweden AB (CTR)


CTR tillkännager att styrelsen har utsett Karin Meyer till ny verkställande direktör. Karin Meyer efterträder Mats Lindquist som varit verkställande direktör sedan starten av CTR 2016. Karin Meyer har en lång erfarenhet av ledande befattningar inom läkemedels- och biotechindustrin, god branschkännedom och en mycket god förståelse för utveckling av nya produkter inom dessa områden. Karin, … Continue reading Karin Meyer blir ny VD för Center for Translational Research Sweden AB (CTR)

Ira Palminger Hallén

New senior consultant: Ira Palminger Hallén


We are happy to welcome Ira Palminger Hallén to RegSmart! Ira has over ten years’ experience as a regulatory expert covering nonclinical and clinical drug development. She has been a nonclinical assessor at the Swedish Medical Product Agency (MPA) reviewing toxicological/pharmacological documentation in drug applications from early development to market approval. Furthermore, Ira was Clinical … Continue reading New senior consultant: Ira Palminger Hallén

Meet us at NLS Days 2019!


RegSmart are excited to announce that we will attend the Nordic Life Science Days 2019 in Malmö, Sweden, the 10-12th of September. We are happy to tell you all about how we can help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency … Continue reading Meet us at NLS Days 2019!

New senior consultant: Agneta Larhed


Agneta Larhed has joined RegSmart AB as a senior consultant with focus on pharmaceutical development and quality/CMC. RegSmart is a newly started regulatory consultancy firm based in Uppsala. Agneta has a broad experience within formulation development and regulatory quality documentation. In addition, she has been active as a manager and researcher within both industrial pharmaceutical … Continue reading New senior consultant: Agneta Larhed

Center for Translational Research AB establishes a new regulatory company


Center for Translational Research AB (CTR), holding company for CTC Clinical Trial Consultants AB, starts a new regulatory consulting company with focus on pharmaceuticals and medical device. Marie Gårdmark has been assigned as CEO for the new corporation. The company will be further strengthened with senior regulatory competence within the areas of medical device and … Continue reading Center for Translational Research AB establishes a new regulatory company