Regulatory submission

In Regulatory & approvals

Also known as: marketing authorization application, MAA, new drug application, NDA

A regulatory submission is the dossier a company files asking an authority to approve a product for sale. It brings together the manufacturing, non-clinical, and clinical evidence, including the clinical study reports and the underlying datasets. Most authorities require it in a standard electronic structure so reviewers can navigate any submission the same way.

Turn the vocabulary into a career

The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.

Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.