RegFile is regulatory affairs and medical writing. We write and publish marketing authorisation eCTD dossiers and run marketing authorisation applications / new drug applications. We handle post-authorisation regulatory affairs, with focus on the Nordic region.

RegFile is headquartered in Uppsala, Sweden and is part of the Centre for Translational Research (CTR) group, together with our sister companies RegSmart, Clinical Trial Consultants (CTC), Toxicology Knowledge Team (TKT) and Lablytica.