Patient Information Leaflet (PIL) User Testing

Spectrum Regulatory Solutions is one of the leading EU providers of PIL user testing. We have a dedicated team conducting tests on PILs for ethical, generic, OTC, herbal and combination products - whether in the form of in-pack paper leaflets, fix-o-form label-leaflets, booklets, labels on tubes, cartons, spray cans, bottles and miscellaneous applicators. Our clients include companies large and small, across Western and Eastern Europe. Our tests have supported centralised, DCP, MRP and national submissions, and we respond rapidly to authority requests for information if necessary.

Clients can choose to have our full user testing service which includes:

• PIL writing in compliance with current EU templates and guidelines
• Design and layout; mock-up generation
• Subject recruitment and screening
• Pilot testing and full interviewing
• Data analysis and feedback
• Submission-ready reports and bridging reports

Alternatively, bespoke packages include simply recruitment, interviewing and reporting.

Full-time recruiting activity to our database means we offer a fast turnaround, usually completing the tests within 4-6 weeks of receiving the final mock-ups.

We will review your portfolio to develop a bridging strategy, thereby reducing the testing volume and associated costs.

Translations

Spectrum offers a dedicated translation service in all EU languages. Our translators provide pharmaceutical and medical translations ranging from marketing literature for medicines and devices to PILs and SmPCs - for which they have a proven track record of approval. All translators are native speakers of the target language, and have to have a recognised qualification in translation, or at least 3 years' relevant experience in the pharmaceutical field. In addition to their translation qualifications, many translators have pharmaceutical or medical qualifications.

We also conduct user testing outside the UK in non-English languages.

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