Two regulators, two sets of expectations
Pharmaceutical companies submitting to both ANVISA in Brazil and the FDA in the US need documentation that satisfies each regulator's specific requirements — even when the underlying clinical or manufacturing data is the same.
Documents that typically need translation
Registration dossiers, clinical trial protocols, GMP audit documentation, and package inserts (bulas) are among the most commonly translated documents for companies operating across both regulatory environments.
Consistency across submissions
Keeping terminology consistent between the Portuguese and English versions of a submission reduces the risk of questions or delays during regulatory review.
Key takeaways
- ANVISA and FDA submissions both require careful, regulator-specific translation.
- Common documents include registration dossiers, protocols, and package inserts.
- Consistent terminology across language versions helps avoid review delays.
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Pharmaceutical companies working with both Brazilian and US regulators face two sets of documentation standards.