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PIL User Testing Expert Support in European Regulatory Affairs

PIL User Testing

EU legislation requires that new marketing authorisations (MAs) must include evidence that the PIL is clear and understandable to potential users. In the UK, this must be achieved by 1st July 2008. To ensure this requirement is met, Regulis conducts user testing and produces a submission ready report. Our testing is never sub-contracted.

At Regulis, we believe in a multi-stage approach that can be tailored to meet your specific needs. Our brochure contains more details on the testing process. We can advise on the most efficient and effective sampling strategy for a range of products. This means it is not necessary to user test every PIL.

We offer a fixed fee service for a single leaflet test. For this we guarantee an MHRA approval, irrespective of how many rounds of testing are required.

Testing and delivery of a submission ready report is normally completed within 8-9 weeks from an agreement to proceed.

 

(If you are interested in joining our extensive panel of leaflet testers, please contact us)