Regulatory Language Infrastructure™
Regulatory language infrastructure for LATAM approval — twelve regulators, six-step pipeline, one signed certificate per file, one guarantee.
8+ source languages. 12 LATAM regulators. Direct source-to-target translation. No English pivot. No two-hop terminology drift.
One target: a dossier that COFEPRIS, ANVISA, INVIMA, ANMAT and other regulators accept on the first pass — translated straight from Chinese, Japanese, Korean, German, French, Italian, Hebrew, or English into Latin American Spanish and Brazilian Portuguese. Nothing routes through an English intermediate on the way.
The matrix is free and public. It cites the resolution, decree, or circular behind every requirement, so your regulatory affairs team can check our reading against the primary instrument before you ever send us a file. Regulators across the region revised submission and language rules in 2024 and 2025 — a lot of vendor knowledge in this market is still quoting from 2019.
Built for the filers who don't author in English
Mindray · United Imaging · BeiGene · WuXi Biologics · Takeda · Daiichi Sankyo · Olympus · Samsung Bioepis · Celltrion · Bayer · Boehringer Ingelheim · Sanofi · Menarini — and every sponsor, manufacturer, and CRO whose source dossier was written for NMPA, PMDA, MFDS, EMA, or AMAR before Latin America was on the roadmap.
These names identify categories of filer the service is built for. They are not clients.
Executed by the operator team behind Amavita Sciences™
Sponsors whose LATAM regulatory work was executed by the same team that built Amavita Sciences™. Case studies published at bioaccessla.com.
Why this exists
If your dossier was authored in Chinese, Japanese, Korean, German, French, Italian, or Hebrew and you want it in front of a Latin American regulator, there are three kinds of vendor you can hire. None of them is built for that job.
Global agencies
Regional LATAM shops
Domestic LSPs in Shanghai, Osaka, Seoul
So you run the two-hop
Where Amavita sits
At the intersection nobody staffed: origin-language reading and LATAM regulator fluency, in one shop, on one file, with one owner.
Amavita Sciences™ is not one of eleven Latin American translation vendors. It is the one purpose-built for non-English pharma and MedTech entering the region — multi-source LATAM regulatory translation as a category, not as an add-on service line.
Source languages
Every language below goes directly into Latin American Spanish and Brazilian Portuguese in a single hop, in the target variant the receiving regulator reads — Mexican Spanish for COFEPRIS, Argentine Spanish for ANMAT, Brazilian Portuguese for ANVISA.
中文
Chinese medical device translation for LATAM: technical files, IFUs, labels, and risk-management summaries straight into Spanish and Brazilian Portuguese. Simplified and Traditional.
Mindray 迈瑞医疗 · United Imaging 联影医疗 · MicroPort 微创医疗 · Neusoft Medical 东软医疗
中文
Translate a Chinese pharma dossier for COFEPRIS and ANVISA without an English intermediate — CTD modules, protocols, and stability reports.
BeiGene 百济神州 · Innovent 信达生物 · Sino Biopharm 中国生物制色 · WuXi Biologics 药明生物 · Hansoh 梁森制色 · Shanghai Fosun Pharma 复星医药
日本語
Japanese pharma translation for ANMAT and INVIMA filings, plus device technical files and IFUs for the whole region.
Takeda · Astellas · Daiichi Sankyo · Otsuka · Terumo · Olympus
한국어
Korean biosimilar dossier translation into Spanish and Portuguese — comparability data, clinical summaries, and labeling.
Samsung Bioepis · Celltrion · LG Chem · SK Biopharmaceuticals
Deutsch
German medical device translation into Spanish and Portuguese, plus MDR-era technical documentation repurposed for LATAM registration.
Bayer · Boehringer Ingelheim · Merck KGaA
Français
French dossiers, SmPCs, and patient leaflets into Latin American Spanish and Brazilian Portuguese.
Sanofi · Servier
Italiano
Italian marketing-authorization packages and post-approval variations into both LATAM targets.
Menarini · Chiesi
עברית
Hebrew-source device and pharma documentation from Israeli exporters, handled without an English relay step.
Israeli MedTech and specialty pharma exporters
English
The origin language everyone else supports. We support it too — it is simply not the only door in.
US and UK sponsors, manufacturers, and CROs
Targets
Latin American Spanish (es-419), delivered in the country variant each regulator expects, and Brazilian Portuguese (pt-BR) for ANVISA. Two targets, 12 LATAM regulators, one terminology base that travels with you across studies and countries.
Two verticals · drugs and devices in both
CLINICAL RESEARCH TRIALS
MARKETING AUTHORIZATIONS
Six patterns
Eight source languages read in the original, by named buyers we already work with — not generic language pairs. Your Chinese technical file is translated by someone reading Chinese, not by someone reading a translation of it.
Submission requirements across the region moved in 2024 and 2025. We cite the primary instrument behind every requirement — Colombia's Resolution 1959/2020, ANVISA's RDC 855, and equivalents across the other regulators — and date-stamp what we find, in public.
Client documents run through zero-data-retention infrastructure on AWS Bedrock, under a HIPAA-eligible BAA, with no prompt or output retained outside the workflow. Your regulatory affairs team can verify how a draft was produced, not just what it says.
Expedited-review pathways differ by origin and destination. Japan's MHLW-recognized fast track: yes. Korea's MFDS fast track: yes, for filings after July 2026. China's NMPA: no equivalent fast track into LATAM today. We map this before you file, not after a delay.
12 LATAM regulators and eight source languages on one engagement, one terminology base, one owner — checked by Six QC gates producing a four-tier findings report (Critical, High, Medium, Low) on every batch. No vendor-to-vendor coordination sitting on your desk.
One origin-language dossier fans out to 12 LATAM regulators in parallel — not one regulator per week for three months. The certificate chain reconciles across all 12 at export time.
The LATAM regulatory matrix · free and public
Which countries demand a sworn translation and which accept a translator's certificate. Which accept English for parts of a dossier. Which require the Spanish variant of that country specifically. Each answer cites the resolution, decree, or circular it comes from — with the date it was issued — so you can check us before you hire us.
Mexico
es-MX
Brazil
pt-BR
Colombia
es-CO
Argentina
es-AR
Chile
es-CL
Peru
es-PE
Ecuador
es-EC
Panama
es-PA
Traducción Oficial · Tradução Juramentada
Traducción Oficial in Spanish-speaking Latin America and Tradução Juramentada in Brazil are not descriptions of care taken. They are legally reserved titles. Only an individual sworn translator, licensed and registered with a national or provincial body, may produce one.
Typically for documents entering a judicial or civil-registry process, and for specific administrative filings named in a country's own regulation. Brazil requires a Tradução Juramentada by a translator registered with the state commercial board for a defined set of foreign-origin documents.
Large parts of a regulatory dossier. Many LATAM regulators accept a translation accompanied by a certificate of accuracy signed by the translator or the translation provider. Paying sworn rates across an entire dossier is a common and expensive misreading of the rule.
We are not sworn translators and we do not present ourselves as one. We prepare regulator-ready text and issue a signed certificate of accuracy. Where a filing requires the sworn step, we route it to a licensed translator in that country and it is priced separately, visibly.
Primary sources behind Section 7. Dates are the last time we verified the text against the official gazette or authority portal (ISO YYYY-MM-DD). Matches the companion PDF.
Mexico · Consejo de la Judicatura Federal (CJF)
Acuerdo General 25/2020 — Lista de Peritos Traductores Auxiliares de la Administración de Justicia
Clause: Art. 3 & 8 — accreditation and stamping requirements for perito traductor.
“Los peritos traductores autorizados por el Consejo de la Judicatura Federal están facultados para emitir traducciones con validez oficial en procedimientos judiciales federales, debiendo estampar su firma, sello y número de registro en cada foja.”Verified: · https://www.cjf.gob.mx
Mexico · COFEPRIS
Ley General de Salud, Reglamento de Insumos para la Salud
Clause: Art. 167 & 170 RIS — foreign-language documents must be accompanied by a Spanish translation; sworn translation required only where the source is a foreign public document requiring apostille (e.g. CPP, GMP).
“Los documentos otorgados en el extranjero deberán presentarse legalizados o apostillados y acompañados, en su caso, de la traducción al español efectuada por perito traductor autorizado.”Verified: · https://www.gob.mx/cofepris
Brazil · Ministério da Justiça / Juntas Comerciais
Lei nº 14.195/2021, art. 26 (revising Decreto nº 13.609/1943)
Clause: Tradutor Público e Intérprete Comercial (TPIC) — sworn translation attaches legal effect to foreign-language documents used before Brazilian authorities.
“Nenhum livro, documento ou papel de qualquer natureza, exarado em idioma estrangeiro, produzirá efeito em repartições da União, dos Estados ou dos Municípios, sem ser acompanhado da respectiva tradução feita por tradutor público.”Verified: · https://www.planalto.gov.br
Brazil · ANVISA
RDC nº 09/2015 (clinical research) and RDC nº 359/2020 (registration dossier)
Clause: Foreign-language dossier components accepted with Portuguese translation; sworn (juramentada) translation required for apostilled foreign public documents such as CPP and GMP certificates.
“Os documentos em idioma estrangeiro deverão ser apresentados acompanhados de tradução para o português, sendo exigida tradução juramentada nos casos de documentos públicos estrangeiros legalizados ou apostilados.”Verified: · https://www.gov.br/anvisa
Argentina · ANMAT / Colegio de Traductores Públicos de la Ciudad de Buenos Aires
Ley Nº 20.305 (Traductores Públicos) & Disposición ANMAT 6677/2010
Clause: Traducción pública required for foreign public documents; regulator accepts qualified translation for scientific/technical dossier content.
“Todo documento redactado en idioma extranjero que se presente ante repartición, entidad u oficina pública nacional deberá ser acompañado de la respectiva traducción al idioma nacional, suscripta por traductor público matriculado.”Verified: · https://www.argentina.gob.ar/anmat
Colombia · INVIMA
Decreto 677 de 1995 & Circular Externa INVIMA sobre documentación en idioma extranjero
Clause: Spanish translation required for all foreign-language documents; official (oficial) translation required for apostilled public documents.
“Los documentos en idioma diferente al español deberán presentarse con traducción oficial, cuando se trate de documentos públicos apostillados o legalizados.”Verified: · https://www.invima.gov.co
Chile · ISP — Instituto de Salud Pública
Decreto Supremo Nº 3/2010, Reglamento del Sistema Nacional de Control de Productos Farmacéuticos
Clause: Art. 22 — foreign-language documents must be submitted with a translation; sworn (traducción oficial) required for public documents.
“Los antecedentes en idioma extranjero deberán acompañarse de su respectiva traducción al idioma español; tratándose de documentos públicos, la traducción deberá ser oficial.”Verified: · https://www.ispch.cl
Peru · DIGEMID
D.S. Nº 016-2011-SA, Reglamento para el Registro, Control y Vigilancia Sanitaria
Clause: Art. 32 — translation into Spanish required; sworn translation required for apostilled foreign documents.
“La documentación en idioma extranjero deberá presentarse traducida al español; cuando se trate de documentos públicos, la traducción será efectuada por traductor público juramentado.”Verified: · https://www.digemid.minsa.gob.pe/
Ecuador · ARCSA
Resolución ARCSA-DE-026-2016-YMIH y actualizaciones
Clause: Foreign-language dossier documents accepted with certified translation; sworn translation reserved for apostilled public documents (CPP, GMP, powers of attorney).
“Los documentos emitidos en el extranjero deberán presentarse apostillados o legalizados y acompañados de la traducción oficial al idioma español cuando corresponda a documentos públicos.”Verified: · https://www.controlsanitario.gob.ec
Panama · MINSA — Dirección Nacional de Farmacia y Drogas
Ley 1 de 2001 y Decreto Ejecutivo 178 de 2001
Clause: Foreign-language documents must be translated to Spanish; sworn translation required for apostilled public documents.
“Los documentos redactados en idioma extranjero deberán acompañarse de su traducción al español efectuada por traductor público autorizado cuando se trate de documentos públicos.”Verified: · https://www.minsa.gob.pa
Educational summary of publicly available regulation, not legal advice. Requirements move. The matrix carries the dated citation for each country.
Questions
Most clinical dossiers move in 5–10 business days per target language, and marketing-authorization packages in 10–15 business days. The exact timeline depends on source volume, language pair, and whether a sworn translation is required. We confirm the schedule in writing before the first file moves, and we do not compress the human certification step to hit a rush date.
We translate directly into the Spanish variant required by Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Chile (ISP), Peru (DIGEMID), Ecuador (ARCSA), and Panama (MINSA), plus Brazilian Portuguese (ANVISA). Every locale is formatted for the specific regulator, not generic Latin American Spanish.
Client documents are processed in a private inference environment with no prompt or output logging to ordinary systems. Nothing is used to train third-party models. Files are retained only for the minimum period needed to deliver, review, and certify the batch, then removed automatically. Translation memory and glossary data stay in your isolated workspace. Business Associate and Data Processing agreements are available on request.
The Dream Outcome
Imagine your next Latin America program running like this:
Protocol, ICF, and site training packages arrive certified, per country, on the schedule you set.
ANMAT, COFEPRIS, ANVISA, INVIMA, ISP, DIGEMID, ARCSA and MINSA each get a package aligned to their local rules — not one generic file forced to fit.
Every deliverable ships with signed certificates, version history, and a complete audit ZIP.
Your translation memory travels with you across studies, indications, and countries — so drift disappears.
The Pharma Annuity
Once you clear a LATAM regulator, the license doesn't just sell product — it triggers a decade of mandated renewals, variations, and safety updates. Every one requires translation. Every one is on our platform.
ANVISA (BRAZIL) MA VALIDITY
Renewals, variations, and PSURs every cycle.
COFEPRIS (MEXICO) MA VALIDITY
Plus mid-cycle variations for every label or formulation change.
PSUR & VARIATIONS
Every safety update, every labeling change, every new indication — all translated.
The Vehicle
Five steps, every batch, every jurisdiction.
Drop your source pack — protocols, IFUs, labels, correspondence.
The platform maps every clause, table, and field before a word is translated.
Domain-tuned models translate against your translation memory + glossary.
Rules engine flags anything ANMAT (Argentina), COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), ISP (Chile), DIGEMID (Peru), ARCSA (Ecuador), or MINSA (Panama) would reject.
Registered linguists in the target country review, correct, and sign.
EVERY STEP LOGGED. EVERY VERSION SIGNED. EVERY AUDIT PREPACKAGED.
What You Get
In every target Spanish/Portuguese variant your program requires.
Per document, per linguist, per version — ready for regulators and IRBs.
Country-specific headers, disclaimers, and layout applied automatically.
Your terminology grows with every study — no lock-in, no vendor hostage.
Source, target, diffs, certificates, signatures, and workflow logs — one download.
One program lead across countries — not a new PM for every language.
Two Buyers · One Workflow
FOR CLINICAL & PHARMA SPONSORS
FOR MANUFACTURERS REGISTERING IN LATIN AMERICA
Why Amavita™
THE USUAL WAY
THE AMAVITA™ WAY
Proof & Trust
Every batch is reviewed and signed by linguists registered in the target jurisdiction — such as CTPCBA in Argentina — before it leaves the platform.
Client documents run through a zero-data-retention environment. Prompts and outputs never enter ordinary logs or third-party training.
We test integrations on synthetic documents you help us design. No protected health information moves before your legal team approves.
A batch releases when every document has passed platform checks, jurisdiction rules, and a signed human certification. No partial deliveries.
The First-Pass Acceptance Program
This is not marketing language. This is the written guarantee attached to every batch we deliver, backed by Six QC gates producing a four-tier findings report (Critical, High, Medium, Low) and adversarial back-translation on 100% of content.
We define 'critical error' precisely in your SOW: numeric mistakes, unit swaps, negation flips, entity substitutions, and any deviation the regulator would treat as a rejection ground.
Every document passes six deterministic gates — structural inventory, numeric integrity, unit consistency, negation preservation, entity mapping, and adversarial back-translation — producing a four-tier findings report (Critical, High, Medium, Low) before a human sees it.
Every gate, every fix, every signature is hashed into a per-document ledger. Regulators, sponsors, and auditors get a downloadable proof-of-quality ZIP with each delivery.
If a document we delivered is rejected on translation grounds, we re-issue at no cost within 48 hours and credit $2,500 per business day of resulting submission delay against your next invoice.
Full terms in the master services agreement. Applies to dossier-critical documents delivered under the First-Pass Acceptance Program tier.
Pricing
Every tier includes adversarial back-translation, Six QC gates producing a four-tier findings report (Critical, High, Medium, Low), and a signed certificate of accuracy. Tier 1-A adds the First-Pass Acceptance Program guarantee.
TIER 2
$35 / page
For non-dossier internal documents that still need certified accuracy.
TIER 1-B
$75–95 / page
$0.19–0.24 / word
For protocols, ICFs, IFUs, technical files, and site-facing clinical or MedTech content.
TIER 1-A
$120–150 / page
$0.30–0.38 / word
For dossier-critical documents: CTD Modules 2/3, SmPCs, PILs, PSURs, drug MA submissions, device registrations.
What's included in every Tier 1-A batch:
Total bundled value: $16,000+ per batch. Included in every Tier 1-A engagement.
Per-word comparison
Volume pricing available above 500 pages per batch. First document is free — no credit card, no commitment. NDA available on request.
Q4 2026 pilots locked at 2026 rates. H1 2027 rates increase.
Free first document offer expires December 31, 2026.
Prefer a printable PDF for procurement? Get the Tier 1-A vs Tier 1-B rate card →
| Feature | Tier 1-A | Tier 1-B |
|---|---|---|
| Best for | Dossier-critical submissions | Clinical & MedTech content |
| Price per word | $0.30–0.38 | $0.19–0.24 |
| Price per page (250 words) | $120–150 | $75–95 |
| Standard turnaround (≤10K words) | 3–5 business days | 5–7 business days |
| Rush turnaround (≤10K words) | 48 hours | 72 hours |
| Re-issue SLA if translation-grounds rejection | 48 hours | 5 business days |
| Deliverables package | Certified PDF + editable source + back-translation + audit ZIP + regulatory review memo | Certified PDF + editable source + back-translation + audit ZIP |
| Six-Gate QC | Included | Included |
| Signed certificate of accuracy | Included | Included |
| Adversarial back-translation | Included | Included |
| Jurisdiction-ready formatting | Included | Included |
| Translation memory + glossary | Included | Included |
| Complete audit ZIP | Included | Included |
| First-Pass Acceptance Program | Included | |
| $2,500/business-day delay credit | Included | |
| Re-issue if rejection on translation grounds | Included | Included |
| Dedicated regulatory affairs review | Included | |
| White-glove submission support | Included | |
All tiers include the same Six-Gate QC workflow. Tier 1-A adds the financial guarantee and dedicated regulatory review layer.
Not sure which tier fits your dossier?
If your submission is dossier-critical, new to this regulator, or on a tight window, start with Tier 1-A and remove the downside. If you are updating an already-accepted dossier, Tier 1-B is the right fit.
How We Start
45 minutes. You walk us through your Latin America program — countries, document types, timelines, and constraints. We listen.
We come back with a written scope: which documents, which countries, on what schedule, with what acceptance criteria.
You sign. We deliver. Together we score the outcome against the criteria you set. Then — and only then — we talk about scale.
Your Next Step
Send us your target countries and document types. We'll come back within one business day with a scoped pilot proposal and a suggested discovery time.
We onboard four new sponsors per quarter. Two Q4 2026 slots remain.
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