ANVISA Dossiers, Clinical Trials & FDA Submissions
Brazil's pharmaceutical market is the largest in Latin America — and one of the most regulated. STIB Solutions provides specialized Portuguese–English translation for every stage of the ANVISA regulatory cycle, clinical research, and cross-border FDA submissions.
Why Pharma Translation Demands Specialists
ANVISA is considered one of the world's strictest pharmaceutical regulators. A registration dossier for a new drug can run 1,000–3,000 pages, encompassing clinical study reports, manufacturing validations, stability data, and pharmacovigilance plans — all requiring certified Portuguese translation before submission.
Terminology errors in clinical protocols, consent forms, or package inserts are not just quality failures — they can invalidate studies, trigger CONEP review panels, and carry direct legal liability. STIB's pharmaceutical translation team includes bilingual regulatory affairs specialists with direct ANVISA and FDA submission experience.
Regulatory Bodies We Cover
Documents We Translate
- ANVISA registration dossiers (Petição de Registro)
- Clinical trial protocols (CAAE / IRB submissions)
- Informed consent forms (TCLE)
- IND / NDA / BLA applications for FDA
- Good Manufacturing Practice (GMP) audit reports
- Pharmacovigilance & adverse event reports (PSUR/PBRER)
- Medical device technical files (INMETRO)
- Package inserts (Bulas) — EN ↔ PT-BR
- Standard Operating Procedures (SOPs)
- Drug Master Files (DMF)
- CMED pricing petitions
- Stability study reports
1,400-Page ANVISA Dossier — 12 Days
"Our ANVISA dossier for a new oncology product was 1,400 pages. STIB translated the full package in 12 days, including clinical study reports and manufacturing SOPs. ANVISA approved the submission without a single request for clarification on the translation."
Common Questions
Can you translate a full ANVISA registration dossier?
Do you handle informed consent forms (TCLE)?
Are your pharmaceutical translators qualified?
Related Resources
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