Regulatory Document Production Services
Accurate. Professional. Submission-Ready.
Copyediting and Formatting for Regulatory Documents
In regulatory submissions, every detail matters. From consistent formatting to precise grammar and terminology, high-quality presentation supports clear communication with regulatory authorities. Our document production services ensure your clinical and regulatory documents meet industry expectations and agency requirements—down to the last character.
What Is Regulatory Document Production?
Regulatory document production (also known as copyediting and formatting) is the final stage of document preparation prior to submission. It includes:
- Thorough copyediting for grammar, clarity, consistency, and regulatory tone
- Formatting to agency templates and sponsor style guides
- Numbering, cross-referencing, and hyperlinking
- Quality control reviews and publishing preparation
These services are essential for INDs, NDAs, BLAs, CTDs, CERs, protocols, clinical study reports, and other regulatory deliverables.
Why It Matters
Small inconsistencies or formatting errors can reflect poorly on your submission or even introduce risk during review. A polished, professional document helps:
- Build reviewer confidence
- Ensure compliance with agency formatting expectations
- Minimize technical issues during eCTD publishing
- Reduce the burden of internal revisions and rework
Our Copyediting and Formatting Services Include:
Grammar, punctuation, and consistency editing
Formatting for submission readiness (including page layout, font, headings, and tables)
Cross-reference verification and hyperlinking
Template development and style guide adherence
PDF optimization and QC checks for publishing handoff
Integrated Support for Complex Submissions
Whether you need standalone editing or end-to-end document support, GLOBAL integrates seamlessly with your workflows. Our writers and editors are trained in regulatory templates and have extensive experience across all major submission types. We collaborate closely with medical writers, SMEs, and publishers to ensure alignment across teams. We also offer:
- Embedded FTE support for large-scale or high-volume projects
- Coordinated delivery across multiple document types or submission modules
- Flexible support models tailored to your timelines and tools
Why Choose GLOBAL for Document Production?
For over a decade, GLOBAL has supported sponsors with regulatory writing and document production services that meet the highest standards of quality and compliance. Our experienced editors ensure your documents are not only technically sound but also clear, professional, and ready for submission.
What sets us apart?
Deep experience with regulatory content and agency expectations
Familiarity with sponsor-specific style guides and templates
Integrated QA process to reduce error rates and streamline review
Proven ability to support complex global submissions under tight timelines
Start clean. Finish strong.
A well-edited, professionally formatted document reflects the integrity of your data and the credibility of your team. Let GLOBAL help you deliver submission-ready documents with confidence.
Contact us today to learn how our document production services can improve quality, reduce turnaround time, and ensure consistency across your regulatory deliverables.
