EU CTD Modules 1 and 3

I am preparing a European Common Technical Document and need a regulatory affairs professional to take full ownership of two key components:

• Module 1 – Administrative & Prescribing Information
• Module 3 – Quality (ICH M4Q format)

All scientific reports, analytical data, stability studies, draft SmPC/labeling texts and other source documents are already available; your task is to compile, gap-check, cross-reference and format them into an EMA-ready CTD that passes technical validation on the first attempt. This includes building the detailed Table of Contents, ensuring consistent pagination and section numbering, applying current EMA/ICH templates, and flagging any deficiencies you spot in the supporting data.

Please be comfortable working with Word and PDF publishing tools and, ideally, have hands-on experience with eCTD compilation software—even though the initial deliverable is a paper CTD, I want it structured so an electronic sequence can be created without re-work later.

Deliverables
1. Draft Modules 1 & 3 for my review (Word)
2. Final, submission-ready versions in bookmarked, hyperlinked PDF
3. A brief hand-over memo highlighting any outstanding risks or data gaps

If you have successfully led EU CTD submissions before, I would love to see a redacted sample or two. Let me know your estimated timeline and any clarification you need so we can get started right away.