EU dossier preflight
Find Module 1 gaps before validation does.
Supply the submission context, attach the dossier evidence you have — or declare which Module 1 sections you hold and run it with no upload — and receive a cited first-pass report for qualified RA review.
Included in the Team plan · no final compliance decisionReview shape
A deficiency list with an evidence trail.
The workflow keeps applicant evidence, regulatory requirements, and unresolved assumptions separate so an RA professional can review each finding.
- Evidence found
- No explicit supporting file identified.
- Source
- EU Module 1 eCTD Specification v3.1.1 (June 2025), section 1.6; Directive 2001/83/EC, Art. 8(3)(ca).
- Reviewer action
- Confirm applicability and attach the current evidence.
Three controlled steps
- 01Set the scope
Procedure, product type, target countries with the RMS first for MRP and DCP, stage, API origin, and the Module 1 sections you hold.
- 02Attach evidence, or don't
Attach dossier files, which stay in the conversation unless a team member explicitly shares them — or run from your declared section inventory without uploading anything.
- 03Review findings
Present, missing, unclear, or not applicable—with citations and reviewer actions.
No account required
Create a Module 1 scope brief now.
Enter the submission context to download a practical evidence-request brief. This brief is free and needs no account. No files are uploaded, and it does not claim that a dossier has been assessed — the cited preflight that does assess evidence runs on the Team plan, and your answers carry over when you continue to it.
Free Module 1 scope brief
Define the submission scope and download an evidence-request brief without signing in.