Periodic Safety Update Reports (PSURs), PSUR translation sit at the centre of post-marketing pharmacovigilance in Europe. Every marketing authorisation holder knows they are part of the ongoing obligation to monitor a medicine's benefit-risk profile. Yet one question...
Are you looking to take your pharmaceutical products into new markets? Every drug that enters a new country brings a documentation requirement with it. Labels, patient information leaflets, regulatory submissions, and pharmacovigilance reports all need to be accurate...
Translation memory gives life sciences companies a strong foundation for efficient and consistent translation. It helps teams reuse previous work, reduce repeated effort, control costs, and maintain continuity across document versions. For regulated industries,...
Clinical trials run on tight timelines, and all key documents must be translated, reviewed, and approved before studies can begin. Delays in translation can delay the entire trial, especially across multiple countries. Clinical trial documents are highly regulated. A...
Managing product information across EU markets is time-consuming. Every approved change triggers translation updates, artwork revisions, and packaging reprints across up to 24 language versions. Electronic Product Information (ePI) offers a different approach. Instead...
Most life science companies tracking the EU AI Act amendments have been focused on the high-risk AI documentation requirements, the technical files, instructions for use, and database registrations. In April, those deadlines were pushed back to 2027 and 2028. What did...
The European Commission proposed the EU Biotech Act on December 16, 2025. Final adoption is expected in late 2026 or 2027. Until then, the December 2025 proposal text is the working document every life science company should be reading. The Act does not change one...
Most medical device manufacturers invest heavily in translation during the pre-market phase, localising IFUs, labels, and packaging across EU member states ahead of CE marking. That effort is visible, deadline-driven, and budgeted. What comes after is far less visible...
Europe accounts for around 26.4% of the global medical device market. For manufacturers entering the EU, label compliance is one of the practical requirements to get right, and one that is frequently misread. Many manufacturers approach the physical medical device...