Field notes
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
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7 posts matching your filters
12 min read
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
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
8 min read
Traditional language services providers deliver a translated document. Regulatory Language Infrastructure delivers the translated document plus the evidence system that makes it defensible at audit.
By Julio G. Martinez-Clark
16 min read
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
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
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