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Package Information Leaflet
Writing, Reformatting and Translations

Pharma EU PIL (Package Information Leaflet) related services:

Writing:

  • Pharma EU writes your Package Information Leaflet in the QRD format ready for user testing. Our PIL writing experience is exemplified by our experience with PIL user testing.
  • Pharma EU PIL writing experience includes all Therapeutic Areas.
  • Any PIL written by Pharma EU is guaranteed for the life of the product. We can make amendments to ensure marketing authorization.
  • We can write your Package Information Leaflets to comply with all EU health agencies.
  • Contact us for more information and samples of previous work.

Reformatting of PILs

  • We can reformat and reorder your package information leaflets to comply with the latest guidance across the EU, Most previously approved PILs already on the market will need to be reformatted and user tested.
  • The MHRA requires well written leaflets, even on existing products.

Mock Up Creation

  • Pharma EU creates mock-ups using either Quark Express or Adobe Programs.
  • We comply with all National Agency Specifications as well as your company’s design specification.
  • Our Mock-ups are delivered ready for printing.

Translations:

  • Pharma EU translates PILs to all European languages using our network of certified medical translators.
  • PILs are translated into target languages by a native-speaker of that language.
  • Certified translations.
  • Translations are proofread by separate native-speakers of the target-language to ensure accuracy and quality of the translation.
  • Please contact us for the CV of the translator of your target-language.

Quality Control of Translated PILs

  • Pharma EU validates the quality of translated PILs to comply with authorities by using a patients’ rights group in the target-country to ensure quality of the translation.
  • Contact us for more information.

More about User testing of PILs here.

Web design: Michaela Freeman (c) 2007 www.Pharma-EU.com: Pharma-EU, s.r.o.