Readability user testing is requested in EAEU October 15, 2020

Readability user testing is requested in EAEU

Does your company know that User Testing of Patient Information Leaflet (PIL testing/ Readability user testing (RUT)) of medicines is requested in EAEU region according to decision of the Eurasian Economic Commission (EEC) No. 88.?

To conduct PIL testing, you should:

  • be familiar with the EAEU rules
  • have appropriate experience in local markets
  • be able to perform testing in EAEU acceptable language.

Inpharmatis is an international consulting company with more than 15 years’ experience in EAEU, CIS and EU markets in the field of regulatory services for pharmaceutical companies.

We are delighted to propose PIL testing in EAEU performed by Inpharmatis - leading provider with great practical experience and expertise of PIL testing in EAEU region.

Inpharmatis has been involved with readability testing since the beginning of the EU requirement in 2005.

We offer:

  • PIL EAEU expertise according to EAEU requirements (also based on previous successful EU experience)
  • Guaranteed Acceptance Across the EAEU requirements
  • Bridging studies for readability user testing
  • Highly qualified multilanguage User Testing Project team located in each country of EAEU
  • PIL GAP analysis versus requirements of EEC Decision No. 88.
  • EU or National PIL reformatting according to EAEU requirements
  • PIL and SmPC translation to most EAEU languages
  • Quick implementation of the project
  • Conduct the validated Readability User Testing in EAEU acceptable languages
  • Validated quality procedures
  • Flexible price

Our approval rates are 100% - leaving aside projects where clients have ignored our initial advice regarding leaflet changes.

If you want to conduct PIL testing and find out further information, please contact us info@inpharmatis.com.

2021 EAEU regulatory changes

January 15, 2021

Webinar: EAEU Regulatory Challenges and Opportunities

November 09, 2020

Readability user testing is requested in EAEU

October 15, 2020

Inpharmatis & Epista Partnership Announcement

September 03, 2020

User Testing Instructions Webinar on 30 April in Russian

April 27, 2020

Inpharmatis Team COVID-19 Update

March 30, 2020

Inpharmatis - Winner in EU GMP Inspection Tender

March 19, 2020

Bебинар: Регистрация и создание досье в электронном формате по новым стандартам ЕАЭС

December 09, 2019

The EAEU Electronic Submission Format

November 20, 2019

Meet us at IV All-Russia GMP Conference 2019

September 23, 2019