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.
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