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.
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
Toxicology Knowledge Team Sweden 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 |
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 Pharmaceutical Industry).
Contact us: info@regfile.se
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, combined with automated, high-throughput bioanalysis carried out by Lablytica Life Science AB, and synchronized dossier writing and submission services from RegFile AB are designed to meet your needs with quality, speed, and precision. Get in touch to learn how we can help shorten your project timelines and achieve your goals faster!
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Are you ready for the IRIS roll-out for Product Lifecycle Management Procedures?
IRIS will become the new submission management system and communication portal at EMA. The first roll-out is live since 23 January 2024, including submission management of variations, Art.61(3) notifications and MAH transfers for a subset of centrally authorised products.
EMA will no longer use EudraLink as communication portal for these products in the procedural steps covered by IRIS.
Later this year PSURs, PAMs, line extensions, renewals, annual assessments, PASS, and referrals will also be rolled out.
Need help? Contact us at info@regfile.se
