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 of Package Information Leaflets and Bridging for
the Generic Industry - download
Submissions (National, CP, MRP
We can reformat and submit your pharmaceutical's dossier to any member state
in eCTD or CTD format.
Compilation / Quality Overview
Our regulatory managers have proven their experience in coordinating and completing
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
PIL, SmPC and Module
We translate medical documents to all European languages using our network of
certified medical translators.