The operating system for multilingual clinical development in Latin America.

Clinical trial translation services convert protocols, informed consent forms, investigator brochures, regulatory dossiers, and site materials into the languages required by local regulators. They combine medical accuracy with regulator-specific formatting and certification. Source: Amavita COFEPRIS and ANVISA regulatory translation guides.

For a Mexico CTA, COFEPRIS expects Spanish translations of the protocol, informed consent form, investigator's brochure, case report forms, and SAE/SUSAR narratives. Device trials add instructions for use, risk analysis, and biocompatibility summaries. Marketing authorization also requires labeling, CMC, stability data, and certificate attestations. Source: Amavita COFEPRIS Regulatory Translation Requirements guide.

Yes. Submissions typically require certification by a perito traductor recognized under Mexican law or a Mexican public translator. The certification must include the translator's full name, credentials, signature, date, and an accuracy-and-completeness statement. Legal instruments such as powers of attorney and apostilles may also need notarization. Source: Amavita COFEPRIS Regulatory Translation Requirements guide.

The four recurring failure modes are (1) terminology mismatches where engines pick Peninsular or South American Spanish instead of Mexican usage, (2) literal renderings of English dosing and safety language, (3) missing or incomplete translator certification, and (4) partial translations where appendices, footnotes, or numbered cross-references drift from the source. Each one restarts the review clock. Source: Amavita COFEPRIS Regulatory Translation Requirements guide.

Legal instruments filed in Brazil — contracts, powers of attorney, corporate authorizations, apostilled documents — must be translated by a tradutor público juramentado registered with a Junta Comercial. In-house or agency certification does not satisfy this. Protocols, Investigator's Brochures, IFUs, and product monographs are technical translations, which must instead align to ANVISA's Vocabulário Controlado and RDC-referenced terminology. Source: Amavita ANVISA Regulatory Translation Requirements guide.

The Termo de Consentimento Livre e Esclarecido is reviewed by the site's Comitê de Ética em Pesquisa (CEP) and, for multicenter or specific-topic trials, by CONEP. Reading level, risk-statement phrasing, and rights language are held to a stricter standard than the protocol itself. A TCLE that reads as a literal machine translation of the English consent is routinely returned for rewrite. Source: Amavita ANVISA Regulatory Translation Requirements guide.

No. Both regulators review dossiers in the local language — Spanish for COFEPRIS and Brazilian Portuguese for ANVISA. Source-language documents are accepted only when paired with a compliant translation that preserves numbering, cross-references, appendices, and footnotes. Standalone translations without the paired source, or PDFs where pagination has drifted, are frequently returned before technical review begins. Source: Amavita COFEPRIS and ANVISA guides.

MD-led review checks clinical intent, safety language, and regulator-specific terminology before submission — mapping terms to ANVISA's controlled vocabulary and Mexican medical usage — so reviewers do not have to send clarifying queries to reconcile synonyms, dosing expressions, or SAE narratives. Fewer queries mean fewer clock resets in first-cycle review. Source: Amavita ANVISA and COFEPRIS guides.

COFEPRIS reviewers expect Mexican medical usage. General-purpose translation engines often default to Peninsular or South American Spanish, and reviewers will flag deviations even when they are technically understandable elsewhere. Regional variant drift is one of the most common sources of first-cycle delay for U.S. and European sponsors. Source: Amavita COFEPRIS Regulatory Translation Requirements guide.

Amavita covers Latin America's major clinical trial and regulatory markets, including Brazil, Mexico, Argentina, Chile, Colombia, and Peru. We deliver Portuguese and Spanish translations aligned to each regulator's expectations.

Submit the pilot intake form at /start-your-latam-pilot. Our team will reach out within 2 business days with a scoped proposal for your protocol or regulatory dossier.