RegFile is now in operation

Earlier this year, Center for Translational Research (CTR) revealed the establishment of a new regulatory company, RegFile AB, complementing RegSmart in its services. RegFile, led by CEO Maria Santesson, is now ready to start providing regulatory affairs support to customers.

Maria Santesson is one of the founders of RegFile and will start as the new CEO on April 5. The board members are Marie Gårdmark, Agneta Larhed and Karin Meyer.


We welcome Maria Santesson to RegFile, and we look forward to seeing the company grow, side by side with RegSmart and the rest of the CTR group”, says Marie Gårdmark, Chairman of the Board at RegFile and CEO at RegSmart.

The operation as well as the website for RegFile is launched today, April 4. The colour theme used for the website and logo is recognised from the CTR logo.

We are happy to be part of the CTR family, and still create our own business. It’s very exciting to start from scratch and to be part of something great being built”, says Maria Santesson, CEO at RegFile.

Check out the new website and our graphic profile at



RegFile contributes with the final regulatory steps in a drug’s journey to marketing authorisation, and beyond. RegFile ensures that all available and necessary data is properly documented, compiled and submitted to the competent authorities. Further, RegFile coordinates the regulatory procedures and handles the regulatory post-market activities.

Besides regulatory affairs support and regulatory dossier writing, the company offer medical and pharmacovigilance writing during drug development as well as acting as the coordinator for regulatory matters pre- and post-authorisation. RegFile will cover the clients’ entire needs in terms of operational regulatory affairs including medical/regulatory writing.

Center for Translational Research Sweden



CTR was founded 2016 and is a group of complementary life science service companies engaged in translational research. CTR is the owner of RegFile, Clinical Trial Consultants, RegSmart Life Science, Lablytica Life Science and Toxicology Knowledge Team Sweden.