Solution · Clinical Trial Localization

Translate a live trial's document set into LATAM Spanish and Brazilian Portuguese.

Protocols, IFUs, labels, informed consent, and regulator correspondence — translated direct from your origin language into es-419 and pt-BR, then jurisdiction-checked against 12 LATAM regulators.

Built for the foreign medtech and biopharma companies running an active trial that now needs COFEPRIS, ANVISA, INVIMA, ANMAT or one of eight more regulators to sign off. No English pivot. No two-hop terminology drift. A signed certificate per file.

See the country-by-country matrix Bring your origin-language dossier

When this shows up

Three moments in a trial when a Spanish or Portuguese file is suddenly on the critical path.

Protocol amendment inbound

Your sponsor issued Amendment 3. Twelve regulators need the revision in their national language, in their national format, before the trial can continue enrolling in-country. The submission clock is running.

Label or IFU change

A device labeling change or IFU update needs to be re-submitted to every LATAM regulator you already have approval from. Each regulator has a different bilingual layout rule and a different footnote convention.

Regulator correspondence

COFEPRIS or ANVISA sent a deficiency letter in Spanish or Portuguese. You need the letter translated into your working language, a response drafted in the regulator's language, and both filed on time.

Proof from adjacent work

The same operators, at regulator scale.

Amavita Sciences™ was built by the same team that has run 159+ LATAM regulatory submissions across 75+ medical device trials since 2010 through bioaccess®. Two recent examples where the regulator dossier language quality had to hold up under years of scrutiny:

Axoft · Harvard Labs spinout · Panama

A brain-computer interface with no predicate. 4 weeks to ethics approval.

When Axoft (Boston, Harvard Labs) needed a first-in-human program for an ultra-soft implantable polymer brain-computer interface with no predicate device, the regulator-facing dossier had to be authored once — in the exact format the Panama CNBI ethics committee reviews against.

Ethics approval landed in 4 weeks. Four patients implanted during brain-tumor resection. The clinical evidence supported a $55M Series A led by C.P. Group Innovation in April 2026.

The lesson: when your device is category-of-one, regulator readiness is not something you retrofit at submission time.

Read the full case study on bioaccessla.com →

Establishment Labs · Nasdaq: ESTA · Costa Rica + Colombia

A multi-year pivotal that survived five years of amendments without terminology drift.

Establishment Labs (Motiva®) ran a multi-year pivotal across Costa Rica and Colombia sites. The dossier had to survive five-plus years of amendments, regulator correspondence, and cross-country consistency checks without the terminology drifting between the Costa Rica submission, the Colombia submission, and the eventual FDA dossier.

On September 27, 2024, the FDA granted Motiva® a PMA — the first new breast-implant PMA since 2013. A PMA supplement for the reconstruction indication landed in December 2025.

The lesson: multi-country, multi-year language consistency is exactly the terminology drift problem Amavita Sciences™ eliminates.

Read the full case study on bioaccessla.com →

Documents covered

Six document families, translated to the exact format each regulator accepts.

Every document below is translated direct from your origin language — Chinese, Japanese, Korean, German, French, Italian, Hebrew, or English — into Latin American Spanish (es-419) and Brazilian Portuguese (pt-BR). Nothing routes through an English intermediate on the way, so terminology decisions made once do not get re-decided per file.

Protocols and amendments

The full study protocol plus every amendment, translated in one linked document set so a regulator can see version history at a glance. Bilingual Layout A means the source page and the translated page ship side by side.

Investigator brochures

IB translated with terminology carried from the protocol translation memory, so the investigator reads the same drug or device name in every document — no synonym drift between IB and protocol.

Instructions for use (IFU)

IFU translated to the specific format each regulator requires — footnote convention, bilingual pagination, and jurisdiction-specific warning language checked against the current resolution.

Product labels

Primary and secondary labels translated with the correct national language ordering (ES over EN for COFEPRIS, EN over PT for ANVISA, etc.) and the country-specific mandatory warning phrasing baked in.

Informed consent forms (ICF)

ICF translated with the mandatory country-specific consent language (Ley 1581 in Colombia, LGPD in Brazil, and so on) checked against the current jurisdictional rule, not against a template from last year.

Regulator correspondence

Deficiency letters, information requests, and inspection findings translated into your working language; responses drafted in the regulator's language on your letterhead, ready for your regulatory affairs lead's signature.

Step two of the pipeline

One Spanish file is not eight deliverables. Eight jurisdiction-checked files are.

After a document is translated, it runs through a rules engine that checks every country-specific requirement — consent language references, label layout ordering, IFU footnote conventions, mandatory warning phrasing — against the current national resolution, decree, or circular. The rules engine is grounded in the country-by-country matrix that is public on this site: every claim we make cites the primary regulatory instrument behind it, so your regulatory affairs team can verify our reading before you ever send us a file.

Consent language

INVIMA (Colombia) requires informed-consent references to Ley 1581 de 2012 on personal data protection. COFEPRIS (Mexico) requires references to the LFPDPPP. The same paragraph, translated once, would not clear either regulator without the jurisdiction-specific citation.

Label layout

COFEPRIS mandates Spanish-first bilingual labels with English secondary; ANVISA allows English on secondary packaging only when the primary label is fully in Portuguese. A single 'Spanish label' does not exist — the layout is part of the deliverable.

IFU footnote convention

DIGEMID (Peru) and ARCSA (Ecuador) each specify a different footnote structure for referencing the underlying technical standard. The translation memory carries the correct footnote pattern per market, applied automatically.

See the country-by-country matrix →

What ships with every deliverable

The certification chain that turns a translation into a submission-ready artifact.

Priced separately, the four items below run $70–$255 per file across the LATAM sworn tier and enterprise US LSPs. Included in every Amavita Sciences^™ deliverable, at no additional line item.

01 · Signed certificate of translation

One certificate per file, signed by the Program Lead.

Signed by the Program Lead, MD. Lists the source file SHA-256, the target file SHA-256, the batch fingerprint, and the seven QC gates that ran. Not a 'translator affidavit' — a full delivery certificate.

Typical market price: $15–$55 per certified file — Diego Heckadon (Panama Traductor Público Autorizado) charges $15 per Certificate of Translation on top of the per-page rate; Silvina Codina (CTPCBA Argentina) charges $15; US retail averages $18–$55 (Sure Translation, The Translation Company, Circle Translations). · Included.

02 · Bilingual Layout A

Source and target laid out side by side, page for page.

Every deliverable ships with the source English page and the target Spanish or Portuguese page laid out side by side. A regulator or a client reviewer can cross-reference paragraph by paragraph without opening a second document.

Typical market price: $30–$80 per page as a certified/notarized clinical add-on (Circle Translations 2026); $58.50–$65/hour DTP at enterprise LSPs (TransPerfect Nevada RFQ, Language Scientific GSA schedule, TechTrans GSA). · Included.

03 · Timestamped audit log

Every pipeline step captured, timestamped, and attributable.

Upload, medical review, regulatory QA, and export are timestamped and signed. If a regulator asks who reviewed a specific paragraph on what date, the answer is in the log — with a signature attached.

Not offered by any of the 11 vendors in the June 2026 bioaccess® EN→ES LATAM RFP, nor by Lionbridge, TransPerfect, RWS, Morningside, or CSOFT on their public life-sciences pages. Category-of-one. · Included.

04 · Batch fingerprint

SHA-256 tamper detection across the batch.

A SHA-256 fingerprint computed over the sorted list of file hashes in the batch, printed on the certificate. If any file in the batch is later modified — by any party, at any point in the audit chain — the fingerprint changes. Evidence-grade tamper detection.

Not offered by any vendor surveyed in the June 2026 bioaccess® RFP or by any of the six named enterprise life-sciences LSPs. Category-of-one. · Included.

Value stack: $70–$255 per file, included.

Sworn certificate + bilingual layout + timestamped audit + batch fingerprint. Priced separately at market rates for the LATAM sworn tier and US enterprise LSPs, this stack runs $70–$255 per file. Every Amavita Sciences^™ Tier 1-A deliverable ships with all four, at no additional line item — because certification, layout, audit trail, and tamper detection are the deliverable, not the upsell.

Market benchmarks: bioaccess^® RFP #2026-06 (11 LATAM/enterprise vendors, June 2026); Circle Translations 2026 medical translation pricing; TransPerfect Nevada RFQ 99SWC-S331; Language Scientific GSA schedule GS-10F-0023K; TechTrans GSA schedule GS-10F-0158V.

Two important clarifications

What this service is not — because a sharp regulatory affairs buyer will ask.

Not "Traducción Oficial"

This is a technical certified translation, not a legally-reserved "official translation."

The phrase "Traducción Oficial" is legally reserved in Colombia (Art. 33, Ley 962/2005 and Resolución 1959/2020), Argentina, Brazil, Mexico, and Panama for translators registered with each country's specific authority. We are not registered in any of those jurisdictions, and we never claim to be. Every certificate of translation we issue carries the explicit "no constituye una traducción oficial" disclaimer in the header band on every Spanish page.

Not a sworn or notarized pathway

For sworn or notarized translation, you need a different provider on that specific step.

Sworn translation (traductor jurado) and notarized translation are separate legal pathways with different signatories, different fee structures, and different turnaround expectations. If a specific regulator step in your submission requires a sworn or notarized translation of a specific document, that step needs a country-registered sworn translator — not the technical certified translation product we ship. We will tell you when this applies; we will not silently substitute.

Questions we hear

Frequently asked questions.

Which document types do you translate for a live trial?

Protocols and amendments, investigator brochures, informed consent forms, IFUs and labels, CRFs, patient-facing materials, and regulator correspondence — the full document set a sponsor moves between origin language and LATAM Spanish or Brazilian Portuguese.

See documents covered →

How do you verify each translation against the right regulator?

Every file is checked against the specific resolution, decree, or circular that governs it in the destination country — 12 LATAM regulators, cited by primary instrument. Your regulatory affairs team can verify our reading against the source.

How jurisdiction check works →

Do you handle sworn certification and apostille?

Yes. Where a country requires a sworn (juramentado / público) translator or apostille, we route through the correct chain and return the certified file. Countries without a sworn regime receive our certification of accuracy instead.

See the certification chain →

What is the turnaround for a live trial document batch?

Standard batches move on the Tier 1-A / Tier 1-B schedules published on the pricing page, with the $2,500/day credit for Tier 1-A misses. Rush routing is scoped per batch.

See tiers and turnaround →

What are you not?

We are not an LLM wrapper, not a general-purpose translation agency, and not a substitute for your regulatory affairs team. We localize the document set — your RA team owns the submission.

Read what this is not →

Two ways to start

Read the matrix, or send us the file.

The country-by-country matrix is a free reference — cite it in your own regulatory affairs work. When you have a live document set to translate, send it and we will scope a pilot batch.

See the country-by-country matrix Bring your origin-language dossier