Dossier
The complete technical and regulatory file submitted to register a product with a destination-country regulator.
Definition
A regulatory dossier is the full set of technical, quality and clinical documentation submitted to a destination country's drug regulator to register a product for import and sale. Dossier requirements range from a full Common Technical Document (CTD) in Tier 1 markets to a lighter 'CTD-lite' format in many Tier 3 markets.
Why It Matters
Dossier complexity is a primary driver of how long and how expensive it is to register the same product in different markets.