The combination of detective work and order was what made Regulatory Affairs interesting for Maria Santesson when she took on the role as CEO of the start-up RegFile in early 2022 The challenge of creating a consulting company based on her own vision attracted her.
Maria Santesson has worked in the consulting industry for many years and has long had a clear picture of how a business can be run and developed in a way that provides both satisfied customers and happy employees. The idea of RegFile is to be a small-scale, flexible consulting company in regulatory services with the opportunity to create long-term, close relationships with its customers.
RegFile is part of the Center for Translational Research (CTR) group, which with its 6 companies offers a wide range of services to life science companies. RegFile was created primarily as a complement to RegSmart, one of the sibling companies that are well known in regulatory, strategic advice.
For RegFile, it is the pharmaceutical dossier that is at the core of the business. The company offers operational regulatory support as well as medical & CMC writing in the late development phase and in the application and maintenance of already approved drugs.
A strong driving force for RegFile is to find creative, optimal solutions and make it easier for the customer to get around in the complex, regulatory world. The small scale of the business enables fast decision-making paths and great flexibility.
”I really want it to be easy, fun and rewarding to work with us at RegFile”, says Maria Santesson. Matching and competence are always the foundation, but to have a fruitful collaboration requires a permissive and humane environment that makes both the own consultants and the customers feel comfortable. Expectations from both customers and employees are checked regularly and there is always room to discuss thoughts and ideas.
Since August, Maria Nilsson Hagberg has also been part of RegFiles’ management. ”It’s a real pleasure to have Nilsson Hagberg on board”, Santesson assures. ”She has extensive regulatory experience from both parent companies and consulting, with all the variety that this entails. In addition, she is both creative and fast in the twists and turns!”
”We really enjoy being consultants and get a lot of positive feedback from customers! You feel that you are doing something important, especially when you support smaller companies. It is easy to forget that the pharmaceutical industry is not just made up of millions of companies. There are a lot of entrepreneurs who are struggling on out there on their own, perhaps with a handful of experts. But it is a huge challenge to make your ideas in life science a reality. Problem solving is what triggers us – you need to keep track of the details and at the same time be able to drive a project forward. We feel great confidence for the coming years”, concludes Maria Santesson.
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