Kategori: News

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

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!

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!

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

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