Field notes
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
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18 posts
12 min read
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
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
15 min read
A cited breakdown of the LATAM regulatory translation market: the $0.05–$0.14 freelance floor, the $0.28–$0.45 Big Four ceiling, and the infrastructure band in between.
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