Pharma-EU.com: Pharmaceutical Regulatory Solutions for the European Union
Consultations with patients regarding the package information leaflets. Guaranteed acceptance across the EU for National, MRP, DCP and CPs.
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)
European Regulatory Pharmaceutical Consulting Services
We can reformat and submit your pharmaceutical’s dossier to any member state in eCTD or CTD format.
Our regulatory managers have proven their experience in coordinating and completing European procedures.
We can work on-site as well as off-site to coordinate variations and maintenance of existing licenses.
Expert support Module 1 for centralized, decentralized, mutual recognition and national procedures.
We translate medical documents to all European languages using our network of certified medical translators.
Preferred Readability Testing Providers for:
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