Document Formatting
Automation Solutions

Manually formatting clinical, CMC, non-clinical, labeling, and regulatory documents to meet external and agency-specific guidelines or your internal rules and SOPs is very manual in most companies and prone to human error. Our automation formats instantly using a library of over 500 rules, ensuring submission-ready documents or compliance to your internal requirements.

Schedule Demo

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Formatting Time Reduction

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Agency & Internal Compliance

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Manual Style Adjustments

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21 CFR Part 11 Compliant

The Challenge: Limitations of Manual
Formatting

At DDi, we know that technical formatting delays submissions. A document may have flawless
data, but incorrect formatting can still trigger quality control failures, extra reworks, or
sometimes agency rejection.

Time-Intensive Work

Adjusting table formatting, finding hidden text, handling alignments, and managing other document layouts across hundreds of pages eats into critical resource time that should be freed up.

Inconsistent Styles

Multiple authors collaborating on a single document often leads to broken styles, mismatched fonts, copy and pasting issues, and irregular paragraph issues.

Complex Guidelines

Adhering to strict corporate templates and SOPs, along with global ICH and eCTD formatting requirements manually, is difficult and heavily error-prone.

Broken Cross-References

Updating tables of contents, lists of figures, and internal hyperlinks manually often results in broken or incorrect navigation.

Our Automated Solution ( REGai ): Document
Formatting Library and Agents

Our automated formatting platform instantly applies pre-defined corporate and regulatory style guides to
your Word documents. From generating accurate Tables of Contents to standardizing table layouts and
fixing broken links, the platform ensures technical compliance without the manual hassle. It can be deployed
across your environment to automate end-to-end publishing pipelines seamlessly.

Instant Style Application

Ensure documents align perfectly with complex corporate templates and precise regulatory expectations in just a single click, eliminating human error entirely.

Automated Restructuring

Instantly correct margins, structural fonts, dynamic spacing, line numbers, and orientation changes across massive sections that would otherwise require hours of manual work.

Dynamic Linking

Automatically build, verify, and refresh complete tables of contents, lists of tables, or structural figures, while completely repairing broken internal in-text references.

Key Capabilities

Comprehensive validation and rapid scanning for modern regulatory operations:

Style Guide Application

Instantly apply pre-configured corporate or regulatory templates to raw text to ensure brand and agency alignment.

Automated TOC and LOF

Dynamically generate, update, and format Tables of Contents, Lists of Figures, and Lists of Tables effortlessly.

Hyperlink and Bookmark Fixes

Validate and automatically repair internal cross-references and ensure structural integrity for PDF bookmarks.

Table Formatting

Standardize table widths, internal borders, repeating headers, and content alignment across the entire document.

Header and Footer Management

Apply consistent pagination, regulatory document IDs, dates, and versioning across complex section breaks.

eCTD Rendition Readiness

Ensure Word documents are perfectly structured for seamless PDF conversion and error-free eCTD publishing.

Benefits of Automating Your Formatting

Empower your teams to focus on data and strategy while software handles the styling:

Enhanced Team Productivity

Let content contributors focus entirely on core data and interpretation, rather than wasting hours adjusting Word margins and fonts.

Accelerated Submissions

Cut document finalization and publisher hand-off time from days to minutes, allowing teams to meet strict regulatory deadlines.

Standardized Output

Ensure every single document looks identical and professional, regardless of which author originally drafted the content.

100% Technical Compliance

Eliminate technical and formatting-related rejections from health authorities to keep submission timelines strictly on track.

Ready to Transform Your Formatting Process?

Move away from manual style adjustments. Adopt an automated formatting solution designed strictly for modern Medical Writing and eCTD compliance.

Schedule a Consultation

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Document Formatting
Automation Solutions

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