Do you need pharmacovigilance support? We provide a full pharmacovigilance setup and QPPV to comply with the pharmacovigilance legislation. We also act as local PV function in the Nordics. And more. Please reach out to [email protected].
RegFile AB
Tillverkning av läkemedel
Regulatory consultancy within the pharmaceutical industry.
Om oss
Regulatory services for pharma industry, such as marketing authorisation application dossier writing and procedure management. Part of Center for Translational Research - CTR group.
- Webbplats
-
http://www.regfile.se
Extern länk för RegFile AB
- Bransch
- Tillverkning av läkemedel
- Företagsstorlek
- 2–10 anställda
- Huvudkontor
- Uppsala
- Typ
- Privatägt företag
- Grundat
- 2022
- Specialistområden
- Regulatory affairs, Medical writing och eCTD
Adresser
-
Primär
Få vägbeskrivning
Eklundshovsvägen 5
Uppsala, 75237, SE
Anställda på RegFile AB
Uppdateringar
-
Autumn arriving! Welcome stress? Autumn arrives to Sweden when the average daily temperature is below 10 degrees five days in a row. Autumn is crisp days and beautiful colours but is also a time of productivity. Sometimes this means a tough work period. If you are struggling with regulatory resources, get in touch with us at RegFile AB: [email protected] Together we will make the fall as delightful as productive! #regulatoryaffairs #regulatoryconsultant
-
-
Excited to be part of the dynamic region Stockholm-Uppsala and its life science sector! Thank you STUNS Life science , Stockholm Science City, Region Uppsala and Region Stockholm for an inspiring afternoon yesterday.
-
-
Topra truly delivers this year! A great network is key to catch on the latest trends and most important changes in the industry. Thanks for all interesting discussions on innovations, AI solutions, new legislation and more. #regulatoryaffairs #toprasymposium
-
-
Finally time for the TOPRA symposium. Elisabeth Widmark will represent RegFile AB and you will find her in the scientific poster area. Welcome! #regulatoryaffairs
-
-
The RegFile team is back to work and ready for a fresh start! Something we are really looking forward to is the NLS-days taking place 18-19 September in Malmö. We will share exhibition booth with our CTR siblings where you are most welcome to visit. There is still time to sign up for NLS if you haven't already. See you there! At booth C09. #regulatoryaffairs #nlsdays
-
-
Are you on top of the upcoming guidelines? The regulatory “bible” for approved products is changing. Obviously, we refer to the “EC guidelines on variations categories and procedures”. Be prepared and check out the proposal for stakeholder consultation: https://lnkd.in/dG2Fv9ZJ There are many changes in this version, relating to IA super grouping, work-sharing, flexibility for vaccines, addition of API suppliers and more. Read the Executive summary for a complete overview: https://lnkd.in/drY8ZJBj We will follow the updates closely and make sure to keep you updated. Greetings from RegFile team
-
-
We are very much looking forward to the NLS days in September, and hope to see you in Malmö. Find us together with our sister companies in the Center for Translational Research Sweden (CTR) booth C09. #nlsdays #regulatoryaffairs
-
-
Welcome to the team Zelmic AB !
Welcome to the CTR group, David Sagna with team at Zelmic AB! Your specialized expertise in topical drug development adds broader pharmaceutical, regulatory, and clinical capabilities to the CTR group. The addition of Zelmic in our company group will enable us to offer a more integrated approach in general, and specifically relating to the IMP GMP manufacturing capabilities, that will benefit our current and new customers. We are all looking forward to having you in the CTR team! CTC Clinical Trial Consultants AB, Lablytica Life Science AB, RegSmart Life Science AB, Toxicology Knowledge Team Sweden AB, RegFile AB, MetaSafe AB, QAlliance AB, CTC Netherlands. #lifescience #translational #consultants #drugdevelopment #CDMO #CTRgroup