AIFA and EMA Knowledge
Translators experienced with AIFA submission formats and EU common technical document (CTD) conventions.
The flags show some of the countries and regions where each language is spoken, not a single country of origin.
Italy is a significant pharmaceutical and medical device market, with AIFA (Agenzia Italiana del Farmaco) governing drug approvals under EU frameworks. Our Italian medical translators combine native fluency with medical or pharmaceutical qualifications and direct experience of AIFA and EMA submission requirements.
For investigator meetings and clinical site visits in Italy, the written work can be paired with professional interpretation services. If a US insurer or a European health authority asks for clinical reports, prescriptions and test results in Italian, certified document translations can be added to the order; check the recipient's rules first.

Translators experienced with AIFA submission formats and EU common technical document (CTD) conventions.
Every Italian medical translation is handled by a translator with a degree in medicine, pharmacy, or life sciences.
Translation, specialized medical editing, and final terminology review using validated Italian medical glossaries.
Patient information leaflets and consent forms reviewed for compliance with AIFA readability requirements.
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Yes. Our Italian medical translators have experience with AIFA-specific formatting requirements and the conventions used in Italian drug approval documentation.
Yes. We build project-specific glossaries and use CAT tools with translation memories to ensure consistent terminology across all documents in a dossier.
Patient information leaflets and consent forms are translated with careful attention to plain-language guidelines and then reviewed by a second translator with patient communication experience.
Yes. All translators and project managers sign GDPR-aligned data processing agreements before receiving any patient-identifiable or trial-confidential material.
Files are transferred over encrypted channels, processed on secure infrastructure, and purged from our systems on project closure unless you request translation memory retention. For Italian sites, we follow both EU GDPR and the Garante Privacy (Italian data protection authority) guidelines applicable to health data.
The time depends on length, language pair and subject, and is confirmed in the quote. A standalone module such as an Italian patient information leaflet (2,000 to 4,000 words) is a shorter job than a complete AIFA drug registration module or 50-page investigator brochure.
For multi-country EMA submissions we can run Italian in parallel with German, French, and Spanish under a single project manager to keep the overall timeline tight.
Send us your files, language pairs, and deadline. We will confirm specialist availability, certification needs, and a clear quote as quickly as possible.