RegFile AB

Welcome to the team Zelmic AB !

It's been a busy and exciting spring for us - but now it is time for meadow flowers and strawberries... midsummer is coming! A wonderful summer to all of you, from the RegFile team🌞

Our engaged regulatory consultants Elisabeth Widmark and Maria Nilsson Hagberg sharing their knowledge and experiences at Läkemedelsakademins new course ”Regulatory strategies” today. #regulatorystrategies

Are you working on a PIP? Please note that paediatric submissions must be submitted via the IRIS platform from 4 June 2024. The following submission types are affected: • Initial paediatric investigation plan (PIP) • Modification of PIP • Product-specific waiver • Compliance check • Annual report • Confirmation on class waiver, or inclusion of an indication • Discontinuation of paediatric development. Not familiar with IRIS? We are. Please reach out for support: [email protected] #pip #iris #paediatric

Varmt välkommen till RegFile Elisabeth Widmark! Vår nya kollega kommer stärka teamet på RegFile med sin gedigna bakgrund från Regulatory Affairs. Elisabeth har arbetat globalt med ett stort antal marknader men även lokalt med dotterbolagens specifika frågor och utmaningar. Därutöver har hon haft ledande roller inom konsultbranschen. Med sin positiva energi och lösningsfokuserade inställning kommer Elisabeth hjälpa våra kunder att nå framgång i sina regulatoriska projekt. ”Jag är taggad att ta mig an min nya roll som senior konsult på RegFile! Med mina 20 år inom Life science hoppas jag kunna bidra med min kompetens och komplettera teamet på RegFile. Jag ser verkligen fram emot nya kundmöten och spännande uppdrag!”

What a lovely evening at Münchenbryggeriet last night, at the SwedenBio Executive Dinner. Many thanks to SwedenBIO for organising the event!

Don't miss this opportunity to learn about Regulatory Strategies at Läkemedelsakademin, including speakers from RegFile AB! Maria Nilsson Hagberg

Buying a complete drug product dossier at an attractive price may be very tempting!   But what are the chances the file is complete and will be pass a marketing authorisation application in Europe?   Let us help. We regularly perform dossier gap analyses against the EU regulatory framework. [email protected] #gapanalysis #regulatoryaffairs #generics #dossier

We got an extra sweet Easter egg this year, filled with our brilliant and sweet siblings at the Center for Translational Research Sweden. We wish all our clients and contacts a sweet and happy Easter too 😊 RegSmart Life Science QAlliance Toxicology Knowledge Team Sweden AB MetaSafe Lablytica Life Science AB CTC Clinical Trial Consultants AB CTC Netherlands RegFile AB

Are you a small life science company and curious about Europe? Then it might be time to get in contact with the European pharma agencies. The first step is to find out whether you qualify as a Small Medium Enterprise (SME). As an SME in Europe, you will benefit from several support programs and get significantly reduced agency fees. This is very helpful when moving forward with regulatory activities as for example Scientific advice. RegFile are happy to support with • SME evaluation and application • PRIME  • Central or national scientific advice • Orphan drug designation request and more... Contact us at [email protected] #regulatoryaffairs #regulatoryconsultants #sme #prime #odd #scientificadvice