Field notes

LATAM Regulatory Translation Blog

Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.

2 posts matching your filters

October 19, 20267 min read
Radiopharmaceutical CMC and import document localization in Latin America: beating the customs decay clock
Short half-life isotopes leave no margin for mismatched CMC, import license and air waybill wording. How to reconcile documents for health, radiation and customs authorities before shipment.
By Julio G. Martinez-Clark
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October 5, 20269 min read
Peru, the Dominican Republic and Uruguay: why one Spanish device dossier does not fit all three
DIGEMID (DS 016-2011-SA), DIGEMAPS (Decreto 246-06) and MSP Uruguay (Decreto 3/008) ask for differently shaped Spanish device files. How to modularize one master file.
By Julio G. Martinez-Clark
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Radiopharmaceutical CMC and import document localization in Latin America: beating the customs decay clock