Regulatory Language Infrastructure™
Pharmaceutical translation services for LATAM submissions — with a Brazil-first operating rhythm.
Translate protocols, labels, dossiers, and regulator correspondence directly from your origin language into Brazilian Portuguese and Latin American Spanish. Checked against 12 LATAM regulators and reviewed by clinicians who understand local submission expectations.
Brazil focus
Built for Brazil from the first file.
ANVISA is not a dialect of FDA. Brazilian submissions require Portuguese terminology, sworn certification, and consent-language standards that do not survive a generic English-to-Portuguese pass. Our Brazil track handles each requirement as a distinct gate.
ANVISA controlled vocabulary
Terms mapped to ANVISA references, RDC terminology, and Brazilian medical usage rather than a literal Portuguese mirror of the English source.
Sworn translation for legal instruments
Contracts, powers of attorney, corporate authorizations, and apostilled documents routed to a tradutor público juramentado registered with a Junta Comercial.
TCLE that passes CEP/CONEP
Brazilian informed consent reviewed for reading level, risk-statement phrasing, and participant rights language before site submission.
Deficiency-letter response in Portuguese
ANVISA exigências translated into your working language, and responses drafted and certified in Portuguese for re-submission.
Document scope
One service for the full pharmaceutical document set.
Protocols and amendments
Translated from your origin language into LATAM Spanish or Brazilian Portuguese, with numbering and cross-references preserved.
Investigator brochures
Medical and scientific intent checked by a clinician before formatting for the regulator.
IFUs and labels
Bilingual layout, warnings, and risk statements aligned to local device and drug labeling rules.
ICF / TCLE
Consent language reviewed for reading level, rights language, and CEP/CONEP or local ethics expectations.
SUSAR / SAE narratives
Safety language rendered precisely to avoid regulator queries during first-cycle review.
CMC and stability data
Manufacturing and chemistry summaries translated with consistent technical terminology.
Registration dossiers
Complete module packages prepared for marketing authorization in Brazil, Mexico, and beyond.
Regulator correspondence
Deficiency letters, responses, and formal submissions drafted in the regulator's language.
How this is built differently
Submission-first translation, not language-only translation.
No English pivot
Documents are translated directly from your origin language into pt-BR or es-419, avoiding two-hop terminology drift.
No generic LSP workflow
Every file is reviewed by a clinician and a regulatory linguist who understands the target regulator's format and vocabulary.
No uncertified submissions
Certification and notarization are scoped per jurisdiction before work begins, so documents are accepted on first filing.
No hidden delay
Tier 1-A includes a $2,500 per business day credit if a delay is caused by our delivery or a critical review error.
Pricing
Tier 1-A: $0.34–0.42/word equivalent.
Tier 1-A includes direct-origin translation into pt-BR or es-419, Six-Gate QC, MD-led review, regulator formatting, certification, and a $2,500 per business day delay credit. The per-word equivalent is based on a 2,000-word clinical document benchmark; actual quotes are scoped per dossier.
Frequently asked questions
Answers for pharmaceutical regulatory teams.
What are pharmaceutical translation services?
Pharmaceutical translation services convert regulatory, clinical, and manufacturing documents into the languages required by local health authorities. For LATAM, that means Brazilian Portuguese and Latin American Spanish, formatted for ANVISA, COFEPRIS, INVIMA, ANMAT, and eight other regulators.
Why does ANVISA require a separate workflow from FDA or EMA submissions?
ANVISA reviews in Portuguese, references Brazilian RDCs, and expects legal instruments to be sworn by a tradutor público juramentado. A U.S. or European translation package will not meet those rules without reworking terminology, certification, and consent-language standards.
Which documents are translated for a Brazil or Mexico submission?
Protocols, investigator brochures, informed consent forms, IFUs and labels, SUSAR/SAE narratives, CMC and stability data, registration dossiers, and regulator correspondence. Each document type has its own formatting and certification rules per country.
What is the difference between a technical translation and a sworn translation?
Technical translations cover clinical and scientific content; they must be accurate and regulator-aligned. Sworn translations are required for legal instruments in Brazil and must be performed by a translator registered with a Junta Comercial. Amavita manages both workflows.
How do I start a pharmaceutical translation pilot with Amavita?
Submit the pilot intake at /start-your-latam-pilot. We will respond within 2 business days with a scoped proposal, sample timeline, and certification plan for your target regulator.
Next step
Start a LATAM pilot with a team that understands the regulator, not just the language.
Tell us about a protocol, submission, or registration on your calendar. We will respond within 2 business days with a scoped proposal for Brazil, Mexico, or your next LATAM market.