european pil user testing in most languages Pharmaceutical Regulatory Solutions for the European Union

Readability User Testing of Package Information Leaflets (PIL)

PIL Readability User Testing
Consultations with patients regarding the package information leaflets. Guaranteed acceptance across the EU for National, MRP, DCP and CPs.


PIL Bridging Studies
Previously tested PILs can be used to support other PILs to create readability testing exemptions.

Readability Testing of Package Information Leaflets and Bridging for the Generic Industry - download (285 kB)
Powerpoint presentation

European Regulatory Pharmaceutical Consulting Services

Submissions (National, CP, MRP and DCP)
We can reformat and submit your pharmaceutical's dossier to any member state in eCTD or CTD format.

Dossier Compilation / Quality Overview
Our regulatory managers have proven their experience in coordinating and completing European procedures.

Post-Approval License Maintenance
We can work on-site as well as off-site to coordinate variations and maintenance of existing licenses.

PIL and SmPC services
Expert support Module 1 for centralized, decentralized, mutual recognition and national procedures.

PIL, SmPC and Module 1 Translations
We translate medical documents to all European languages using our network of certified medical translators.

Preferred Readability Testing Providers for: