RegSmart Life Science AB and RegFile AB announces today that they are merging to offer an even more comprehensive support to companies in pharmaceutical development and medical device. The combined entity will operate under the name RegSmart, with an expanded and deeper range of regulatory services.
“We have had a close collaboration with RegFile for a long time, and this merger feels like a natural step,” says Marie Gårdmark, CEO of RegSmart. “By pooling our resources, we can offer our clients even broader expertise and more comprehensive support.”
RegSmart and RegFile already have an established collaboration, sharing assignments and assisting each other with specialist expertise. By merging into a single company, they are creating a more integrated organization with greater resources and an increased capacity to meet clients’ needs.
“This is a fantastic opportunity for both our clients and our employees,” says Maria Santesson, CEO of RegFile. “By joining forces with RegSmart, we gain access to greater resources and can deliver even higher quality services.”
The merger strengthens RegSmart’s position as a leading player in regulatory consulting and enhances its ability to help companies navigate the complex regulatory landscape of the life sciences industry. Clients will benefit from a smoother process, broader expertise, and even more comprehensive services.
About RegSmart Life Science
RegSmart Life Science is a regulatory consulting firm in the pharmaceutical and medical technology industries. From its headquarters in Uppsala, the company supports businesses in navigating the complex and evolving regulatory landscape. RegSmart’s expertise spans from early research phases to market approval and post-approval processes, with a team of experienced regulatory experts combining scientific understanding with a commercial perspective.
Founded in 2019, RegSmart is part of the Center for Translational Research (CTR), which brings together expertise in life sciences development. With extensive regulatory experience and knowledge of both European and U.S. requirements, RegSmart helps clients develop viable strategies and optimize their path to market.
Learn more at www.regsmart.se