Dossier
The complete set of documents submitted to a regulator for review.
What it means
A dossier is the complete set of documents submitted to a regulatory authority for a clinical trial authorization, marketing authorization, or post-approval change. In Latin America, dossiers include translated protocols, consent forms, regulatory correspondence, CMC data, and supporting legal documents. Formatting and language consistency across the dossier are critical.
Why it matters for LATAM submissions
A dossier is reviewed as a whole. Translation inconsistencies between the protocol, consent, and CMC sections can create the impression of poor quality control and trigger regulator questions.
Relevant regulators
Related terms
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