Trilogy Writing and Consulting Logo

Glossary Terms

Submission dossier

A set of documents to be submitted to the regulatory agencies like EMA (European Medicines Agency) or FDA (US Food and Drug Administration) in order to receive a marketing authorisation for a specific medicinal product. The submission dossier needs to be in the form of a common technical document (CTD).

Use our tool to look up the definition of terms in our glossary.