Drug Regulatory Dossier Preparation

I need a complete CTD-style dossier compiled for a small-molecule drug that is moving toward its first regulatory submission. All source documents—study reports, analytical data, stability tables, method validations, and certificates—are available in draft or final form; what’s missing is the skilled hand that can transform this raw material into a submission-ready package.

The work involves:
• Organising Modules 1-5 in full CTD and eCTD folder structure.
• Formatting, paginating, and hyperlinking every document so it passes technical validation.
• Building the master table of contents and electronic bookmarks.
• Checking each section against current ICH, FDA, and EMA guidance, flagging any data gaps for me to resolve.
• Producing a final compiled set (PDFs plus backbone) that clears a validation tool such as Lorenz or GlobalSubmit without errors.

Acceptance will be based on a clean validation report and my internal quality review.

If you have hands-on experience preparing drug dossiers for regulatory authorities and can keep communication crisp and proactive, I’m ready to share the document list and timelines immediately.