Field notes
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
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18 posts
11 min read
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
13 min read
The Spanish-specific readability index LATAM IRBs increasingly enforce — and why 98.3% of Spanish ICFs already fail it.
By Julio G. Martinez-Clark
14 min read
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
One protocol amendment × 12 LATAM countries = 900 to 1,700 regulated deliverables. Here's the fan-out math and the parallel architecture that closes it fast.
By Julio G. Martinez-Clark
12 min read
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
9 min read
A technical comparison of general-purpose AI translation and MD-led medical review for clinical trials, and why AI alone does not hold up for Phase III documentation.
By Amavita Sciences