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Regulatory Dossier

Meaning

A Regulatory Dossier is a comprehensive, structured compilation of all administrative, non-clinical, and clinical data and information concerning a pharmaceutical product, biological agent, or advanced therapeutic supplement. This extensive body of evidence is formally submitted to a national or regional regulatory authority, such as the FDA or EMA, to support an application for marketing authorization. The dossier must meticulously document the product’s quality, safety profile, and clinical efficacy. The integrity of this document is the single most critical factor for bringing a new hormonal therapy to market.