Bridging Studies for Package Information Leaflets Readability Testing

Previously readability tested PILs can be used to support other PILs creating readability testing exemptions. PILs with similar indications, therapeutic areas, active ingredients or combination medicines can be used for bridging.

Pharma-EU’s three years of readability testing experience qualifies us to write expert bridging studies and assessments. We have completed over 100 bridging studies to date with a 100% success rate.

Bridging Study Reports

We can:

• Identify PILs which qualify for exemption
• Reformat PILs to QRD allowing for bridging study exemptions
• Prepare the bridging studies complete with the CV of the person responsible for preparing the report
• Support the PILs and bridging studies through the procedure as needed

Preferred Readability Testing Providers for: