Agneta Larhed
Senior Advisor
M Sci Pharm, Ph D
agneta.larhed@regsmart.se +46 (0)727- 46 73 50
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About us
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.
The company
RegSmart Life Science
RegSmart Life Science is a regulatory consultancy firm in pharma and medical devices that will help you navigate in a complex and evolving regulatory landscape. With our long experience as regulators the Swedish and Norwegian MPA, combined with previous positions as product developers, 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 analyze and interpret regulatory information in relation to scientific data, finding solutions to drive the project forward. We provide support from early research throughout your product life-cycle, always with the target product profile in mind.
The company
Research in life science
Research in life science is developing at high speed leading to approval of important new products targeting patient for whom previous treatment options have been poor or non-existing. This positive development and scientific progress lead to new regulatory challenges and subsequent development of new legislation and guidelines. We will analyse the current regulatory environment and the available science to give specific guidance and support to help you reach your project goals. We combine scientific understanding with regulatory knowledge to minimize time to market.
Our background
RegSmart
RegSmart was founded 2019. In 2021, we strengthened our team with pharmacovigilance to cover the needs post-approvals. In 2022, we added clinical development plans to our services. Our vision is to create a company building on extensive regulatory experience and on firm scientific knowledge. We believe that progress in research and development comes from teamwork and we are committed to bring the regulatory aspects to the table. By including the regulatory, clinical and commercialaspects early on in the project, the path to market access can be optimized 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 the regulation is heading.
Our background
Meet our team
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Marie Gårdmark
CEO and Senior Advisor
M Sci Pharm, Ph D
marie.gardmark@regsmart.se +46 (0)765 – 27 62 65
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Mats Högberg
Director Medical Device & IVDR, Senior Consultant
MSc, MBA
mats.hogberg@regsmart.se +46 (0) 705 – 46 50 21
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Join our team
At RegSmart we strive, in an open and solution-oriented way, to help small and medium sized companies from idea to market. We see opportunities, navigating in a complex regulatory landscape with the mindset that scientific understanding will open the right doors to reach the goal.
About us
Center for Translational Research AB
Center for Translational Research AB (CTR) is a holding company founded in 2016. The company partly owns RegSmart Life Science AB, CTC Clinical Trial Consultants AB, Lablytica Life Science AB, Toxicology Knowledge Team Sweden AB, Regfile AB, MetaSafe AB, QAlliance AB and CTC Netherlands BV.