10 min read
Preclinical Translation Across 19 LATAM Countries
What LATAM regulators and ethics committees actually require translated for the preclinical annex of clinical trial filings — 19 countries, 5 exceptions named.
By Julio G. Martinez-Clark
Field notes
LATAM Regulatory Translation Blog
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
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9 posts matching your filters
13 min read
INFLESZ Threshold: Why 98% of Spanish ICFs Fail
The Spanish-specific readability index LATAM IRBs increasingly enforce — and why 98.3% of Spanish ICFs already fail it.
By Julio G. Martinez-Clark
16 min read
The RFI Anatomy: Six LATAM Rejections Deconstructed
Six real translation-grounds RFIs from INVIMA, ANVISA, COFEPRIS, ANMAT, ISP and DIGEMID: the flagged clause, the error, and the delay each caused.
By Julio G. Martinez-Clark
11 min read
Sworn vs. Certified Translation: When Each Applies
A document-by-document, country-by-country read on when LATAM and global regulators require a sworn public translator, when a certified statement is enough, and when neither is required at all.
By Julio G. Martinez-Clark
12 min read
Which Regulators Accept English Dossiers?
A module-level map of submission-language rules for devices, pharmaceuticals, and biologics across LATAM and the major global authorities — including where English is accepted and where it never is.
By Julio G. Martinez-Clark
12 min read
Translation QC for Regulatory Dossiers
How to build a translation quality process a regulator can audit — fidelity checks that catch meaning drift, tiering you can defend in writing, and terminology control across thousands of dossier pages.
By Julio G. Martinez-Clark