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
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