According to the bridging guidelines, not every package insert requires readability user testing!
Bridging is a cost and time-saving alternative to the legally required proof of readability via readability user testing. This is achieved by referring to previously successfully tested package inserts in the case of medicines:
Our bridging studies include:
We review your package inserts and create the bridging report in accordance with current guidelines,
such as the
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: 04.06.2019