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
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
11 min read
Costly Translation Mistakes in Regulatory Filings
Eight recurring translation mistakes in regulatory submissions, what each one costs in money and calendar time, and the decision rules that prevent sponsors from paying for certification tiers no authority requires.
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