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!
Center for Translational Research Sweden AB (CTR) acquires Toxicology Knowledge Team Sweden AB (TKT) further strengthening the CTR group with optimised toxicological support. From April 1, TKT is a fully owned subsidiary to the holding company CTR. The activities at TKT will continue without interruption and with the same staff, in the same facilities in … Continue reading CTR acquires preclinical toxicology company
Welcome to RegSmart, Katarina Andersson, senior consultant! Our new senior consultant Katarina has a long-standing experience as a pharmaceutical inspector, pharmacovigilance (GVP). Most recently, Katarina comes from the Swedish Medical Products Agency (MPA), where she spent twelve years as an inspector, whereof the last six years as Head of the GVP/GCP group of inspectors. She … Continue reading New senior consultant: Katarina Andersson
Our new senior consultant Robert is a pharmacist with a PhD in medical cell biology. Most recently, Robert comes from the Swedish Medical Products Agency, where he spent eight years as a clinical assessor. As a clinical assessor he has reviewed a number of market authorisation applications as well as providing scientific advice to companies. … Continue reading Welcome to RegSmart, Robert Hägerkvist, senior consultant!
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)
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
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!
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 (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