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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14 min read
Preclinical Translation Requirements Across 9 LATAM Regulators
What ANVISA, COFEPRIS, INVIMA, ANMAT, ARCSA and the rest actually require for Module 4 nonclinical documentation — tier by tier, with the conservative default when guidance is silent.
By Julio G. Martinez-Clark
12 min read
What global regulators actually require for translating preclinical dossiers
A source-anchored companion to the LATAM piece — what FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA, and Swissmedic actually require for Module 4 nonclinical documentation, with the conservative default when guidance is silent.
By Julio G. Martinez-Clark