Vi är stolta och glada att få vara med och bidra till Kunskapsportalen med två kurser för innovatörer inom life science. Kunskapsportalen är en plattform med utbildningar inom ämnen inom som produktutveckling, immaterialrätt, specifika regelverk och affärsutveckling. Det är SweLife tillsammans med svenska inkubatorer och innovationskontor med life science-inriktning som står bakom initiativet. Läs mer… Fortsätt läsa Kunskapsportalen – EU marketing authorisation procedures
Nordic Life Science Days is one of these yearly events we look forward to the most. It is usually very well-organised with a lot of networking opportunities. This time RegFile will be sharing booth with friends from the CTR Group. You are welcome to drop by the multicoloured puzzle for a chat and some sweets.See you… Fortsätt läsa Meet us at the CTR stand at NLS days in Malmö
We are strengthening the group within medical & regulatory writing. Åsa with her particular interest in writing scientific texts on complex subjects, will complement RegFiles perfectly. She has a Ph D in immunology and is experienced in drug development and in the writing of scientific overviews. ”It feels exciting and stimulating to work with such… Fortsätt läsa Åsa Jansson to RegFile
Lina Påve is a regulatory CMC specialist. After many years as a quality assessor at the Swedish Medical Products Agency, she has solid experience in assessing module 3 documentation for a wide range of pharmaceutical substances and formulation forms. With her skills she becomes an important part of the team when we help our customers… Fortsätt läsa Lina Påve to RegFile
We are so happy to welcome Maria Nilsson Hagberg to RegFile! With some 20 years of experience from regulatory affairs in pharma industry and as a consultant Maria will have a given role as a senior regulatory consultant and also a part of the RegFile management. Maria has a wide experience from clinical trial applications… Fortsätt läsa Maria Nilsson Hagberg to RegFile
The first episode of the podcast Idé till patient (Idea to patient) will be released on April 12. The podcast series is a co-production between the companies within the CTR-group and SwedenBIO. The series comprises six episodes where invited guests from the pharma industry will be discussing the pitfalls and highlights in early drug development. Episodes 2-4… Fortsätt läsa CTR launches podcast together with SwedenBIO
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… Fortsätt läsa RegFile is now in operation
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… Fortsätt läsa CTR establishes regulatory company, complementing RegSmart
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
