A dossier is the argument you make to a regulator that your product is safe, effective and of consistent quality. A complete one is not simply long. It is organised so that a reviewer can find what they need, in the format their authority expects.
The common structure
The Common Technical Document (CTD) organises a submission into five modules: regional administrative information, summaries, quality, nonclinical and clinical. Many African authorities accept CTD or a close variant, and some accept electronic (eCTD) submissions, while others still expect paper or a defined folder structure.
Why a gap analysis pays for itself
Queries from a regulator can add months. A gap analysis before submission, comparing your core dossier with each authority’s checklist, catches the missing certificate or mismatched specification while it is still cheap to fix.
ECP prepares, reviews and submits dossiers across African markets, and supports the variations and renewals that follow approval.
