Readability Testing

Spectrum Regulatory Solutions is one of the leading European providers of readability testing for patient information leaflets (PILs), package leaflets (PLs), healthcare professionals instructions and educational materials.

We have successfully completed the testing of over 700 PILs across a broad range of therapeutic areas. In fact, several of our user-tested leaflets have featured in the MHRA's "PIL of the Month".

We have an extensive database of several thousand members of the general public, healthcare professionals and specific patient groups whom we can draw upon to undertake testing and ensure swift turnaround times.

PL Writing & Design

The combined experience and learning we've gained from over 700 PIL tests means we're experts in writing clear and user-friendly product information, labels and instructions.

We can help you with:

PIL writing in compliance with current EU QRD templates (Centralised, Decentralised and Mutual Recognition procedures) and guidelines
Design and layout of leaflets; mock-up generation

Patient Information Leaflet (PIL) Readability Testing

Because clear patient information means more effective treatment, reduced risks and greater patient safety, we understand the importance of rigorous testing, delivered within time and budget.

We offer:

Testing (full and focus) and bridging strategies for large portfolios to reduce time and costs
Pilot testing and full/focussed interviewing
Submission-ready reports and bridging reports
Testing on all forms of patient information for all product types and dosage forms
Linguistic review, testing and reporting in most major European languages besides English

Our Services include:

Support for Centralised, DCP, MRP and national submissions, and rapid response to authority requests for further information if necessary
Readability testing of diverse documents such as educational materials and medical device handling instructions

Our tried and tested process and dedicated team of PIL user testing experts offers rapid turnaround and a high quality leaflet testing capability. Your leaflet testing is in safe hands with Spectrum.

Read an example case study

To find out more, download our readability testing brochure. Or call us today on +44(0)1403 320280.

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Spectrum Regulatory Solutions, Fraser House, 14 Carfax, Horsham, West Sussex RH12 1DZ regulate@spectrumrs.com. Spectrumrs.com is the trading name of Spectrum Regulatory Solutions Ltd. Spectrum Regulatory Solutions is a limited company registered in England and Wales with company number 5331222. Registered office: St James's House, 8 Overcliffe, Gravesend, Kent DA11 0HJ. VAT registration no: 818283318