Kategori: News

Let us share some great regulatory tips from Läkemedelsverket (Swedish Medical Products Agency). They have published a list of well-thought-out tips directly from their quality assessors directed to pharma companies. The list details how to compile your quality (CMC) related variation applications in the best way. Take a look:@https://lnkd.in/denRJuGa CONTACT US

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. CONTACT US

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… Fortsätt läsa Will we meet at Nordic Life Science days?

The regulatory “bible” for approved products is changing. Obviously, we are talking about the “EC guidelines on variations categories and procedures”. Be prepared and check out the proposal for stakeholder consultation: european-commission-guidelines-variations-categories-procedures-proposal-stakeholder-consultation-track-changes_en.pdf (europa.eu) There are many changes in this version, relating to IA super grouping, work-sharing, flexibility for vaccines, addition of API suppliers and more.… Fortsätt läsa On top of the upcoming guidelines

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… Fortsätt läsa PIP submission via IRIS

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. CONTACT US

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 RegFile RegSmart Life Science  QAlliance  Toxicology Knowledge Team Sweden AB  MetaSafe  Lablytica Life Science AB  CTC Clinical Trial Consultants… Fortsätt läsa CTR Easter egg

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… Fortsätt läsa Is Europe next?

Do you need guidance when promoting your medicinal product or interacting with healthcare professionals? Do you need a pair of extra eyes to ensure high ethical standard and to navigate regulations and industry standards? We help you ensuring compliance with the ”Ethical rules for the pharmaceutical industry” as set by LIF (Swedish Association of the… Fortsätt läsa Promoting your medicinal product

Are you in need of a combined generic drug bioequivalence testing and submission service? In the fast-paced world of registering generic products, time is of the essence for running the bioequivalence (BE) study, performing the bioanalysis, and writing the marketing authorisation application dossier (eCTD).  Our specialized clinical trial unit, provided by Clinical Trial Consultants AB,… Fortsätt läsa Fast-tracking generic submissions