Are you ready to launch?

When your Marketing authorisation is granted, many local regulatory activities are still required prior to commercial launch. These requirements vary significantly between countries, and we recommend you to carefully plan the marketing in collaboration with local experts. Below some actions that usually involve Regulatory Affairs: – Strategy for common packs and serialisation – Application for… Fortsätt läsa Are you ready to launch?

What about some regulatory medical writing

A regulatory Medical Writer combines knowledge in both writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards. The RegFile team support you in producing high quality documents ready to be shared with agencies, such as: clinical and non-clinical overviews and summaries, Periodic Safety Update reports,Briefing documentation for… Fortsätt läsa What about some regulatory medical writing

Learning with RegFile: eCTD overview

RegFile’s next contribution to Kunskapsportalen is the presentation ”eCTD overview”. Kurskatalog (learnifier.com)Kunskapsportalen is a platform created by SweLife and contain trainings within product development, , business development, specific regulations and intellectual property. Swedish incubators and innovation offices are behind the initiative. Read more: https://swelife.se/kunskapsportalen-sjosatt%ef%bf%bc/Create an account in Kunskapsportalen: Kurskatalog (learnifier.com)

Merry Christmas! God jul! Happy holidays!

Thank you for a great first year in business. We are longing for 2023!

Jobba med oss

Vi söker förstärkning inom regulatory. Har du några års erfarenhet från industri eller myndighet – välkommen att söka! Se hela annonsen här:  Open position #1    

New year. New regulations.

Do you know what is happening in regulatory next year? 2022 is coming to an end and we are looking forward towards 2023. Here we list some important regulatory changes:   CTISOn Jan 31, 2023, The Clinical Trials Information System (CTIS) will become mandatory for submission of Clinical Trials in Europe. Sponsors can use CTIS… Fortsätt läsa New year. New regulations.

Kunskapsportalen – EU marketing authorisation procedures

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

Meet us at the CTR stand at NLS days in Malmö

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

Åsa Jansson to RegFile

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 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