EMA has launched a new pilot to assess whether the analysis of ‘raw data’ by regulatory authorities improves the evaluation of marketing approval for new medicines. The pilot will run for 2 years starting in September. Still, regulatory decisions within EU are based on the assessment of applicant’s own analyses, which in turn must be thoroughly … Continue reading Potential step change – EU regulators get to play with data
This autumn, you joined the RegSmart team as senior consultant medical device and IVD. Tell us, what is your background prior to joining RegSmart? I have a PhD in pharmaceutical sciences but instead of pursuing an academic career, I started my own consultancy business. Consultancy suited me well, and for the last decade I have … Continue reading Welcome to RegSmart, Jennie Andersson, senior consultant medical device
You have been a part of the life science industry for more than 30 years, and are a familiar face to many of us. You also hold a PhD and are Associate Professor in Physical Chemistry at KTH in Stockholm. Tell us, what is your background within life science? I have been responsible for pharmaceutical … Continue reading Welcome to the RegSmart team, Torbjörn Wärnheim!
On June 1, you joined the RegSmart team as Director medical device and IVD, with a senior consultant role. Tell us, what is your background prior to joining RegSmart? I am a senior executive with global experience in the medical technology and life sciences market. Over the past 30+ years, I have worked in several … Continue reading Welcome to RegSmart, Mats Högberg, Director medical device and IVD
You have just joined our team as senior consultant, drug development. What is your background, prior to joining RegSmart? I am a pharmacist, with vast experience from a wide variety of drug product formulations intended for different administration sites, e.g. oral, parenteral and dermal routes. Most recently, I come from the Swedish Medical Products Agency, … Continue reading Welcome to RegSmart, Eva Ragnarsson, senior consultant drug development
Many people are dependent on their pacemaker to live normal lives. It is an ingenious innovation – but did you know that it is a Swedish invention? Mats Artursson, senior consultant at RegSmart, has been deeply involved in the pacemaker development since the 1980s. Up to 700 developers in Sweden, US and India contributed along … Continue reading What would a pacemaker be without medical device software?
RegSmart has teamed up with LBR Regulatory as US Agent partner, and offer full support for non-US companies to introduce projects to FDA in a cost effective way. Why an US Agent? For foreign pharmaceutical or medical device companies to enter the US pharmaceutical market, you need to have an authorized US Agent, acting like … Continue reading Planning to open an IND in US?
Do you know regulatory affairs CMC? Do you want to use your knowledge in the very front of pharmaceutical development? At RegSmart we support innovative companies with our regulatory expertise. As Senior Consultant, you will get to work with a variety of projects, with many different companies. At RegSmart, there are always colleagues ready for … Continue reading Join our team – as Senior CMC Consultant
In January 2023 you joined our team as senior consultant, medical devices. What is your background, prior to joining RegSmart? Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for eight years, as Assessor and Inspector, responsible for in-depth investigations of market surveillance cases with focus on medical … Continue reading Welcome to RegSmart, Mats Artursson, senior consultant medical device
RegSmart Life Science and the business incubator Uppsala Innovation Centre (UIC) has signed a partner agreement starting February 1, 2023. RegSmart will support UIC start-up pharma and medical device companies with regulatory advice. RegSmart will also contribute to UIC’s special offerings to the Life Science community companies. Uppsala Innovation Centre (UIC) offer innovative startups and … Continue reading RegSmart new partner at Uppsala Innovation Centre (UIC)
Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true. Above all, notified bodies have a limited capacity following the stricter requirements since the MDR came into force. … Continue reading Unclear proposal from the EU Commission on how to solve the MDR challenges
