Pharmaceutical & Healthcare Translation

Yes. For pharmaceutical projects, all translators hold advanced degrees (PhD or Master's) in life sciences fields — pharmacology, chemistry, medicine, or regulatory affairs — in addition to professional translation certification. We do not assign pharmaceutical documents to linguists without subject matter credentials.

Yes. STIB has translated full ANVISA Petições de Registro exceeding 1,400 pages, including clinical study reports (Module 5), manufacturing documentation (Module 3), GMP certificates, DMFs, and package inserts. Our largest single pharmaceutical project was 1,800 pages delivered in 14 business days.

Yes. The TCLE is a particularly sensitive document — it must be in plain language for patients while being legally and scientifically precise. We translate and culturally adapt TCLEs for CONEP/IRB approval, ensuring the language meets both ANVISA and ICH E6(R2) plain language standards.

Absolutely. Brazilian pharma companies with promising compounds increasingly file INDs and CTAs with the FDA and EMA. We translate Brazilian clinical data, manufacturing documentation, and regulatory correspondence into English — with FDA-specific formatting and terminology.

We maintain a continuously updated bilingual glossary of ANVISA-specific regulatory terminology that differs from the international ICH standard. For example, "CONEP" vs "IRB", "CAAE" vs "Protocol Number", "bula" vs "SmPC" — all terms are mapped to their correct ANVISA equivalents before translation begins.

Yes. All pharmaceutical projects are covered by strict NDA. We can sign your organization's standard NDA or provide our own attorney-drafted confidentiality agreement. Translators are also individually bound by confidentiality through their contractor agreements.