A Clear and Defined Process

ELC Group has had proven success with readability tests, focus tests and bridging reports. Our experienced team follows the procedure set by the European Medicines Agency (EMA) and has the capacity to cover all types of submission procedures (Centralised, Mutual Recognition, Decentralised and National. We conduct testing across all therapeutic groups — from simple generic products to more complex biotechnology products. Our aim is to minimize the number of tests performed to expedite your approval process.

 

ELC’s team is prepared to address the various challenges a company can face during the testing stages. Our expertise lies in:

  • Reviewing the leaflet and offering suggestions to keep it simple and easy to understand
  • Creating a questionnaire to cover key safety messages
  • Assessing the best design for the mock-up artwork to maximize space and readability
  • Selecting participants (2 rounds, 10 participants each) and conducting individual interviews; demographics (age, gender, education level) customized as needed
  • Evaluating the testing data to provide constructive feedback for revision of the leaflet
  • Preparing the final report as per EMA requirements
  • Preparing the mock-ups if required

Testing Alternatives: We have had a high rate of success with delivering clients a cost-saving method, which involves conducting focus testing, and preparing a bridging report invarious formats and bridging statement as well.

Key Figures

17+

years of experience and recognition as a market leader for readability testing

4,500+

readability tests and bridges performed

2,450+

package insert leaflets and mock-ups created

100%

success rate for our readability tests; if any query arises, we defend the report in front of the concerned regulatory agency free of charge