Artwork & Labelling

Labelling is high-risk regulatory work: errors drive recalls, field actions and rejections, and they are among the most common and most avoidable. PharmExpert authors and maintains product labelling — SmPC, Package Leaflet, carton and label artwork — and controls the artwork process so what reaches print is accurate, approved and market-compliant.

We author and update SmPC, PIL and labelling texts to current requirements, including EU QRD-template and readability compliance, and manage the changes driven by safety findings and regulatory updates that keep labelling a living obligation.

Artwork is where good text still goes wrong. We apply rigorous, controlled review and version management so only approved, accurate artwork proceeds to print — the discipline that catches the transposed strength or outdated leaflet before it becomes a recall.

Across markets and languages we maintain consistency, mapping how a single labelling change must propagate through every affected presentation. The result is labelling that is compliant, consistent and controlled — protecting patients and your authorizations.