The mission is to support clients with regulatory affairs services in connection to, and beyond, their regulatory submissions for marketing approval. CEO will be Maria Santesson.
“It is with great enthusiasm I take on the task of setting up operational regulatory consulting within CTR, and I look forward to working with all the dedicated experts within the group”, says Maria Santesson.
The new company will contribute with the final regulatory steps in a drug’s journey to marketing authorisation, and beyond. They will ensure that all available and necessary data is properly documented, compiled and submitted to the competent authorities. And further, they will coordinate the regulatory procedures and handle the regulatory post-market activities.
Besides regulatory affairs support and regulatory dossier writing, the company will offer medical and pharmacovigilance writing during drug development as well as acting as the coordinator for regulatory matters pre- and post-authorisation. Their goal is to cover the clients’ entire needs in terms of operational regulatory affairs including medical/regulatory writing.
“The services provided by the new company will be complementing RegSmart’s business perfectly. By working closely together we will cover the full regulatory scope and support companies in all stages of drug development”, says Marie Gårdmark, CEO at RegSmart Life Science and Chairman of the Board at the new company.
Maria Santesson, the new CEO, has long experience within regulatory affairs, pharmacokinetics, medical writing and pharma industry consulting. She holds a Master of Science in pharmaceutical sciences and has been working in both the private and public sector.
“We welcome Maria Santesson to the CTR group, and we are sure that the services offered will be an important complement to the already established businesses within the group”, says Karin Meyer, CEO Center for Translational Research Sweden (CTR).
CTR was founded 2016 and is a group of complementary life science service companies engaged in translational research. CTR is the owner of Clinical Trial Consultants, RegSmart Life Science, Lablytica Life Science and Toxicology Knowledge Team Sweden.
A regulatory consultancy firm in pharma and medical device that will help you navigate in a complex and evolving regulatory landscape. They provide fit-for-purpose advice and support in relation to European and US regulatory requirements, helping their customers to develop the regulatory plan as part of overall project strategy. Their expertise is to analyse and interpret the guidance provided and decisions taken by regulatory agencies and help answer specific questions in projects. They provide support from early research throughout a product life cycle, always with the target product profile in mind.
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
