We do nothing regular within regulatory
We combine regulatory expertise with commercial understanding and scientific experience. After all, it is all about managing risks and expectations. Making sure that your time and money is spent in the best way. Spearheading your work to the next phase. Always with eyes both on the bigger picture and the details. Because both are essential for the end result.
Press release
RegSmart appoints new CEO as part of planned leadership transition
RegSmart has appointed Åsa Magnusson as new Chief Executive Officer, effective 7 April 2026. The appointment is part of a planned leadership transition and supports the company’s continued development and long-term positioning within regulatory science.
Åsa Magnusson brings extensive experience from operational and strategic leadership across the life science sector, combined with hands-on client experience in regulatory, medical and commercial strategy. With a solid understanding of how regulatory and commercial strategy needs to be aligned, Åsa Magnusson will focus on further strengthening RegSmart’s organisation, client offering and long-term direction.
Welcome to Regsmart
Regulatory experts striving to create outstanding conditions for your success.
We support you with regulatory experience based on firm scientific knowledge and commercial understanding. Progress in research and development comes from teamwork, and we are committed to bring the regulatory aspects to the table. By including the regulatory aspects early on in your project, the path to market access can be influenced and time to market minimized.
All projects are different and there are rarely any standard solutions to the challenges in product development. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the individual project.
We will help you look into the future and predict in what direction regulations are heading. Welcome for a first contact!
Our services
Pharma
We provide scientifically based strategic and operational support and strong advice to companies and academia from early research throughout the product lifecycle. We provide regulatory and scientific expertise in all areas of drug development.
Medical Device
As experts in Medical Device Regulation, we support you in developing a clinical development strategy for your medical device, as well as help you develop a cost-efficient regulatory plan and build and implement the required quality management system.
IVD
We have long experience in In-Vito Diagnostic Regulation, and know the requirements when it comes to generating the required clinical evidence. We help you with your IVD device, from clinical development strategy to regulatory plans and implementation.
What we do
Why RegSmart?
Regulatory relevant
Our fundamental understanding of the regulatory requirements and current thinking helps us to develop the best regulatory strategy for your product.
Scientifically sound
We help you design development studies that are consistent with their intended scientific purpose and will gain relevant knowledge for science-based regulatory submissions.
Fit-for-purpose
By combining the understanding of regulatory demands and market dynamics with scientific knowledge we identify the critical steps to be performed and how to present the obtained results in a manner suitable for regulatory and business evaluation.
RegSmart Support
RegSmart supports master’s thesis at EuroDURG 2025
Early this summer, our former master’s thesis student, Elise Nordenberg, presented her project, “A Study of Recent Trends in Clinical Efficacy Evidence for Marketing Authorization of Orphan Medicinal Products by the EMA and the FDA,” at the EuroDURG 2025 conference in Uppsala.
The project explored publicly available data from EMA and FDA, focusing on clinical efficacy documentation in the authorisation of orphan drugs – treatments developed for rare diseases.
Meet our team
The team
Director and Senior Advisor
M Sci Pharm, PhD
agneta.larhed@regsmart.se +46 (0)727- 46 73 50
Read more
Director Medical Device & IVDR, Senior Consultant
MSc, MBA
mats.hogberg@regsmart.se +46 (0) 705 – 46 50 21
Read moreOur motto
We do nothing regular within regulatory
RegSmart Life Science is a regulatory consultancy firm in pharma and medical device that will help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency and from small and big life science companies we facilitate your work by knowing ”what to do, when and how”. We provide fit for purpose advice and support in relation to European and US regulatory requirements, helping you to develop a regulatory plan as part of your overall project strategy. Our expertise is to analyse and interpret the guidance provided and decisions taken by regulatory agencies in EU and US and help answer the specific questions in your projects. We provide support from early research throughout your product life-cycle, always with the target product profile in mind.