“Can you translate more than 600,000 words in 4 weeks for an FDA* inspection? “ That’s “the challenge” that a laboratory specialized in allergy diagnostics presented us.
Additionally, the same laboratory wanted to simplify the management of statements, in order to reduce cost and lead time.
The date of the FDA inspection was non-negotiable and the volume to translate was very significant. (More than 14 times the average volume translated within this time).
The task was to translate the inspection dossier into English, reusing old and scanned content, while ensuring consistency throughout and relying on translation specialists.
The laboratory benefited of our approved procedures (ISO 9001: 2008), our pharmaceutical expertise as well as our rich network of translation specialists (for this project, we could activate more than 20 specialists between translators, reviewers, linguists and terminologists).
The laboratory also benefited from our cutting-edge technologies, which support the creation of a central translation hub (sharing of TMs, glossaries and contents) where specialists can intervene simultaneously and interact.
The inspection dossier was delivered on time, fulfilling all initial requirements and contributing to pass the FDA* compliance inspection.
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*FDA: Food & Drug Administration