Companion Guide
What class of document is this — protocol, ICF, IB, labels, legal-admin, or a technical reading aid?
The destination regulator’s class decides the language work. Open the matching country guide after you classify the file.
Published September 2026
Five document classes
Match the file to the right language rule.
Protocol
Full local language as that country guide requires; not a 3–5 page stand-in. The protocol drives the submission, so the translation must carry the same regulatory weight as the source.
Informed consent (ICF)
Full local language, subject-adapted, as that country guide requires. The ICF is reviewed by ethics committees and read by participants; it must be in the local language and aligned with local comprehension standards.
Investigator brochure (IB)
Follow the destination country guide; some regulators accept the source language plus a local summary, while others require a full local-language IB. Do not assume one approach works for all twelve countries.
Labels and packaging text
Local language or permitted symbols as that country guide requires. For El Salvador, the live SRS guide covers etiquetado castellano on the secondary pack — use it as the reference for that market.
Legal-admin vs. technical reading aid
Legal-admin documents — powers of attorney, apostilles, foreign health-authority certificates — follow the apostille or sworn path: Apostille vs. Sworn Translation in LATAM. Amavita Sciences™ does not claim sworn-translator status. Technical and preclinical reports are a reading-aid translation for the trial file, not a substitute for the legal-admin class. Point to the country guide for the exact depth required.
Country guides
Open the regulator guide that matches the file.
Each country guide states which document class must be fully translated, which can remain in the source language, and which certification path applies. No LATAM-wide statute overrides the local rule.
Next step
Classify the file, then scope the pilot.
Once the document class is clear, the country guide gives the exact language and certification rule. If you are ready to scope a pilot, send the file set through the intake form and we will match each document to the right regulator pathway.