PIP submission via IRIS

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 generic dossier?

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

CTR Easter egg

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

Is Europe next?

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?

Promoting your medicinal product

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

Fast-tracking generic submissions

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

IRIS roll-out for life-cycle management

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… Fortsätt läsa IRIS roll-out for life-cycle management

Let’s finish your UFOs

Any UFOs (=UnFinished Objects) on your desktop? Such as regulatory reports and summaries that you never seem to have time for. Consider our regulatory/medical writing services.   info@regfile.se Let’s finish your UFOs More NEWS & POSTS

Veterinary product information v.9

Have you updated your veterinary product information to QRD v. 9 yet? The EU Veterinary Medicinal Products Regulation (2019/6) entered into force on January 28, 2022, replacing the former directive. The regulation introduced a new version of the QRD template, requiring structural updates to the SmPC, package leaflets and labelling. All existing veterinary products will… Fortsätt läsa Veterinary product information v.9

Struggling with IRIS?

Are you struggling with IRIS and other regulatory systems? At RegFile we regularly make scientific and regulatory submissions via IRIS. We can guide and support you through all steps needed for your submission to reach the agency in good shape. We also offer support with the compilation of background materials, enhanced by subject matter experts… Fortsätt läsa Struggling with IRIS?