LATAM Regulatory Agencies - Preclinical Translation Visual Replication

I sent formal letters to five LATAM regulatory agencies this week asking a question nobody in this industry seems willing to ask out loud. Do preclinical source documents actually require page-by-page visual replication when translated for submission? This is one of the most contentious and least discussed issues in LATAM regulatory translation. Test reports, hazard analyses, cleaning validations, biocompatibility summaries. Sponsors and CROs routinely assume these documents need full desktop publishing to mirror the original layout, table by table, header by header. I have seen it inside my own company. I have seen it across the market. So I went to the source. On August 24 and 25, I emailed the regulatory bodies directly. Peru's INS/REPEC, citing Comunicado 008-2022-DIGEMID. Argentina's ANMAT, citing Disposición 727/2013. Colombia's INVIMA, citing Circular Externa 5000-0001-22. Brazil's ANVISA, in Portuguese. El Salvador's SRS/CNEIS, citing RTCA 11.03.59:18 §7.11.1. Each letter cited the country's own regulation and asked for written confirmation of what the rule actually requires. My position, after reviewing regulatory frameworks across 19 LATAM countries in detail: no regulator mandates visual replication of preclinical source documents. The requirement is accurate translation of content, not reproduction of format. But I do not want my interpretation. I want theirs, in writing. I am still waiting on responses. When they come, I will share them here. In the meantime, Amavita Sciences™ has published the most comprehensive breakdown available on preclinical translation requirements across all 19 LATAM countries. Link in the first comment. If you have dealt with this confusion firsthand, whether as a sponsor, CRO, or translator, I want to hear your story. I am also looking for guests on the Global Trial Accelerators™ podcast who work at this intersection of regulatory translation and submission strategy. Details in the first comment.