10 min read
Preclinical Translation Across 19 LATAM Countries
What LATAM regulators and ethics committees actually require translated for the preclinical annex of clinical trial filings — 19 countries, 5 exceptions named.
By Julio G. Martinez-Clark
Field notes
LATAM Regulatory Translation Blog
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
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12 posts matching your filters
3 min read
How to Choose a Regulatory Translation Partner for LATAM Submissions
Most sponsors treat regulatory translation as a procurement line item. In LATAM, that assumption costs 60 to 120 days per submission. Here is how to evaluate a translation partner that actually understands what each regulator expects.
By Julio G. Martinez-Clark
4 min read
The Hidden Cost of Translation Rework in LATAM Clinical Trials
Translation rework is the largest untracked cost in multi-country LATAM submissions. A $35,000 translation budget can generate $450,000 to $1.8 million in rework costs and deferred revenue.
By Julio G. Martinez-Clark
4 min read
Preclinical Translation Requirements Across 9 LATAM Regulators: What Each Authority Actually Asks For
The same preclinical package filed across LATAM requires nine different translation approaches. Here is exactly what ANVISA, COFEPRIS, INVIMA, ANMAT, DIGEMID, ISP, ARCSA, DNM, and SRS each expect.
By Julio G. Martinez-Clark
4 min read
Why Generic Translation Vendors Fail LATAM Regulatory Submissions
Most translation vendors deliver grammatically correct documents that regulators reject anyway. The problem is not language quality. It is regulatory context, and generic vendors do not have it.
By Julio G. Martinez-Clark
12 min read
Which Regulators Accept English Dossiers?
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