Can regulators keep up with innovation?


New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market, exemplified by CAR-T cells, and the research pipeline is promising. In addition, the medical device field is constantly growing creating new … Continue reading Can regulators keep up with innovation?

New team member at RegSmart!


”We are very pleased to welcome Mats Mårfält to RegSmart. His extensive regulatory knowledge and long experience from pharma industry and Swedish MPA will be most helpful in developing relevant regulatory strategies”, says Marie Gårdmark, CEO at RegSmart. Mats Mårfält is a pharmacist educated at Uppsala university and with a career spanning over 40 years … Continue reading New team member at RegSmart!

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