Pharma-EU.com: 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.
	Patient Consultation Methodology Patient Information Leaflet - Readiabilty Testing Quality Overview PIL Writing and Reformatting PIL Mock-Up Creation
	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.

Readability User Testing of Package Information Leaflets (PIL)