The guidelines do not stipulate that all package inserts require readability user testing.
Bridging cuts costs and saves effort by referring to already successfully tested package inserts. This is suitable in the case of medicines:
We review your package inserts and create the bridging report in accordance with current guidelines:
PAINT-Consult has carried out bridging procedures since 2006, long before the bridging guidelines were introduced. This includes every approval procedure - CP, DCP, MRP and national.
Last update: 30.10.2018