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amavita

A Translational Services Platform for Latin America

Faster clearance. Cleaner audits. One workflow for Latin America.

Amavita Sciences™ moves your clinical and regulatory documents through Latin America with AI-assisted translation and human-certified quality — so your trials start on time and your market clearances don't stall on paperwork.

SPONSORS · MANUFACTURERS · CROs · REGULATORY AFFAIRS TEAMS

The Problem

Latin America is a growth market. The paperwork is where deals die.

Two different buyers hit the same wall — the translation stack. And translation is not one thing. It's dozens of documents, dozens of regulator rules, and dozens of ethics committees pulling in different directions.

SPONSORS RUNNING LATAM TRIALS

Protocols and site materials stall in a patchwork of vendors.

  • Every ethics committee wants its own tweaks
  • Terminology drifts between sites and countries
  • Version control lives in email threads
  • Audit trails are reconstructed after the fact

MANUFACTURERS SEEKING LATAM CLEARANCE

Labels, IFUs, and technical files must match rules that shift by country.

  • ANMAT, COFEPRIS, ANVISA, INVIMA each differ
  • One rejected label restarts the review clock
  • Consultants translate — engineers rewrite
  • Registrations queue behind translation errors

The Cost of Doing Nothing

Every week of translation friction is a week of trial burn or lost market access.

12–20

DOCUMENTS PER COUNTRY

for a single Phase III protocol package

6–14

WEEKS LOST TO TRANSLATION

when handled ad hoc by CROs and freelancers

1

WRONG LABEL

can restart a regulatory review clock

Directional industry ranges. Not audited client data.

The Dream Outcome

Every document ready when your protocol is.

Imagine your next Latin America program running like this:

  1. Site activation is not waiting on translation.

    Protocol, ICF, and site training packages arrive certified, per country, on the schedule you set.

  2. Every jurisdiction sees the version it needs.

    ANMAT, COFEPRIS, ANVISA and INVIMA each get a package aligned to their local rules — not one generic file forced to fit.

  3. Audits are a download, not a project.

    Every deliverable ships with signed certificates, version history, and a complete audit ZIP.

  4. Terminology stays consistent across programs.

    Your translation memory travels with you across studies, indications, and countries — so drift disappears.

The Vehicle

One workflow. AI does the work. Humans certify the outcome.

Five steps, every batch, every jurisdiction.

Upload

Drop your source pack — protocols, IFUs, labels, correspondence.

Structural inventory

AI maps every clause, table, and field before a word is translated.

Draft translation

Domain-tuned models translate against your translation memory + glossary.

Jurisdiction check

Rules engine flags anything ANMAT, COFEPRIS, ANVISA, or INVIMA would reject.

Human certification

Registered linguists in the target country review, correct, and sign.

EVERY STEP LOGGED. EVERY VERSION SIGNED. EVERY AUDIT PREPACKAGED.

What You Get

A complete package, not a stack of files.

Certified translations

In every target Spanish/Portuguese variant your program requires.

Signed certificates of accuracy

Per document, per linguist, per version — ready for regulators and IRBs.

Jurisdiction-ready formatting

Country-specific headers, disclaimers, and layout applied automatically.

Translation memory + glossary

Your terminology grows with every study — no lock-in, no vendor hostage.

Complete audit ZIP

Source, target, diffs, certificates, signatures, and workflow logs — one download.

Single point of contact

One program lead across countries — not a new PM for every language.

Two Buyers · One Workflow

The same platform, tuned to how you buy.

FOR CLINICAL SPONSORS

Run a Latin America trial without the translation traffic jam.

  • Protocols & amendments
  • Informed consent forms (per site)
  • Investigator brochure summaries
  • Site initiation & training
  • Patient diaries & questionnaires
  • Ethics-committee correspondence

FOR MANUFACTURERS SEEKING CLEARANCE

Register products across Latin America without a translation setback.

  • Product labels & packaging inserts
  • Instructions for use (IFUs)
  • Technical files & submission dossiers
  • Risk-management summaries
  • Post-market surveillance updates
  • Regulator correspondence

Why Amavita™

Built by clinicians. Wired for Latin America. Audit-ready by default.

THE USUAL WAY

  • Vendors stitched together per country
  • Terminology drift study over study
  • Certificates arrive as PDFs by email
  • Audit trails reconstructed in a hurry
  • Every language change starts over

THE AMAVITA™ WAY

  • One platform, one program lead across countries
  • Your translation memory grows with every study
  • Signed certificates + audit ZIP delivered with the batch
  • Complete audit log — versioned, timestamped, exportable
  • Rules engine catches jurisdiction issues before humans do

Proof & Trust

Everything a regulator, sponsor, or IRB would ask you to show.

Certified linguists, per country

Every batch is reviewed and signed by linguists registered in the target jurisdiction — such as CTPCBA in Argentina — before it leaves the platform.

Private AI inference

Client documents run through a zero-data-retention environment. Prompts and outputs never enter ordinary logs or third-party training.

Synthetic data during onboarding

We test integrations on synthetic documents you help us design. No protected health information moves before your legal team approves.

All-or-nothing batch release

A batch releases when every document has passed AI checks, jurisdiction rules, and a signed human certification. No partial deliveries.

Our Commitment to You

If the pilot batch doesn't meet your acceptance criteria, you don't sign a longer contract. Full stop.

  1. Scoped pilot, fixed timeline

    A defined document set delivered on a stated schedule so we're accountable on day one.

  2. Acceptance criteria in writing

    Together we define what 'accepted' means — for each document type — before we start.

  3. Your data stays yours

    Translation memory, glossaries, and audit exports are portable. No lock-in.

  4. Named program lead

    One senior person from our side owns your program — not a queue.

How We Start

Three conversations to a signed pilot.

  1. Discovery

    45 minutes. You walk us through your Latin America program — countries, document types, timelines, and constraints. We listen.

  2. Scoped pilot proposal

    We come back with a written scope: which documents, which countries, on what schedule, with what acceptance criteria.

  3. Pilot batch

    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

Let's look at your next Latin America program before your calendar decides for you.

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.

EMAIL

hello@amavitasciences.com

WEB

amavitasciences.com

PROGRAM LEAD

Pedro Martinez-Clark