Pharmaceutical translation has consequences that go beyond professional reputation. A patient information leaflet that misrepresents dosage instructions, a clinical trial document with inconsistent terminology, or a regulatory submission with translation discrepancies can each create serious problems. The standard here is not good enough for the circumstances. It has to be exact.
Our pharmaceutical team works from terminology glossaries built for each client. When your dossier refers to a specific compound, mechanism, or procedure, that term is consistent throughout every document in every language. Reviewers at the EMA or AIFA do not have to guess what the same concept is called on page 47 versus page 140.
We handle SmPC documents, patient information leaflets, clinical study reports, investigator brochures, regulatory correspondence, and module translations for CTD submissions. For Phase I to III clinical trials, we have handled full documentation packages. For marketed products, we handle post-marketing variation dossiers.
All pharmaceutical translation projects include a review stage with a second translator who has a background in the same therapeutic area. For EMA submissions, we also provide a terminology consistency report on request.
What is included
"The clinical trial documentation was exactly right. The EMA accepted it first time." - Dr. M. Ferretti, Brescia Biotech S.r.l.
How delivery works
All files are delivered digitally by email in the format of the original document. For certified translations, the signed certification statement is included as a separate document.