Welcome to RegSmart, Emil Schwan, senior consultant! Our new senior consultant Emil is a pharmacist with experience from performing GMP and GDP inspections, formulation development, manufacturing of medicinal products and pharmaceutical quality systems. He has been chief designer for several types of medicinal products. Most recently Emil comes from the Swedish Medical Products Agency, where … Continue reading New senior consultant: Emil Schwan
“We are very happy to welcome Peter Fröberg to RegSmart as Director, Medical Device. Peter has a long and broad experience from the global medical device sector working with the complete product life-cycle, never losing sight of the market. Peter is a solution-oriented person with a strong record from strategic regulatory decision-making roles and he … Continue reading New Director, Medical Device: Peter Fröberg
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
Do regulatory agencies approve new medicines earlier and with less data today compared to before? This is a question that has been raised during recent years, but is there some truth in this? The basis for regulatory approval of a new drug is that positive benefit-risk profile has been proven. This decision is based on … Continue reading Drug development create new challenges for regulators
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?
“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!
More than 3 years have passed after the vote and there is still uncertainty around the outcome. At this date, however, the UK prime minister has stated very clearly that he will deliver Brexit the last of October. The discussion of the potential consequences for the Life Science business started soon after the vote. Great … Continue reading Brexit looking back and looking forward
Are you a regulatory expert in drug development? Would you like to work with highly skilled colleagues in an entrepreneurial yet safe start-up? In that case, take a look at what RegSmart has to offer! RegSmart is a newly started consultancy firm within global regulatory affairs, drug development. After a flying start, we are looking … Continue reading Are you our new Senior Regulatory Affairs Consultant?
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