User Testing

New regulations that focus on improving information for the user are an integral part of new marketing authorization applications.

Consultation with and the testing of target patient groups is required to demonstrate that patients can find and understand key messages for the safe use of the medicine. Also to ensure that they know how they should act.

Whether you require one test or the testing of your entire portfolio, Unicus provides comprehensive solutions to meet your needs.

Unicus is focused on quality service that is continuously reviewed to evolve with regulatory demands and client needs.

Unicus provides highly experienced team of Regulatory Professionals, Interviewers and Data Analysts to support the testing and reporting of your patient information leaflets. (PIL)

Shou ld you have several similar PILs, we can conduct a portfolio analysis to create a strategy that ensures all of your products reflect user testing at an economical cost.

Our full user tests and reports include:

• Readability review of text
• PIL design and layout guidance.

Other services are

• Bridging studies
• Bridging reports
• Prompt responses to any questions from competent authorities
• Existing PILs to QRD format
• Conversion of SmPC to PIL
• Professional design service
• Translation services.

We have practical experience of a wide range of products and procedures:

• POM, OTC, Generics and Devices.
• Centralised, MRP, Decentralised and National submissions.

Our clients range from large multi-nationals to small start-up companies.