Submissions-ready means more than just a final draft.

Once your documents are written and reviewed, they still need to be formatted, validated, and organized to meet the exact specifications of global regulatory agencies. That’s where our publishing team comes in.

At CDM, we manage every detail of the publishing process—ensuring your files are consistent, correctly formatted, and ready for eCTD submission. From hyperlinking and bookmarking to TOC generation and compliance checks, we handle the behind-the-scenes work that keeps submissions moving forward.

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• eCTD compliance. We format and prepare documents to meet FDA, EMA, and other regional agency requirements.

• Bookmarking & hyperlinking. Accurate internal navigation ensures reviewers can find what they need—fast.

• Version control & metadata. We maintain clean naming conventions, version histories, and PDF properties for submission integrity.

• Final QC. Every document goes through a detailed check to ensure formatting, navigation, and layout are consistent and compliant.

• Seamless integration. We work alongside your writers, project managers, and external vendors to ensure nothing falls through the cracks.

Publishing is the last mile of your submission process—and errors here can lead to delays or rejection. Our role is to make sure your final deliverables aren’t just complete, but correct and regulator-ready.