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Document Formatting, QC & Publishing Automation

From Content to Submission-Ready Documents

Managing Agency as well as company internal rules/guides manually can create significant effort and introduce avoidable risks. Regulatory, medical writing, CMC, labeling, publishing, and quality teams may spend hours checking formatting, validating references, reviewing tables, correcting hyperlinks, updating bookmarks, and ensuring documents comply with agency and internal rule books.

Document automation solutions connect formatting, quality control, and publishing into a streamlined, technology-enabled process.

Using REGai, organizations can automate repetitive document preparation and QC activities using rule-based automation, AI, or a hybrid approach. The result is a more consistent, traceable, and efficient path from working documents to submission-ready output.

Reg-Ops-Solutions_app-mock-updated

70%+

Manual Efforts Reduced

65%

Lower Operating Costs

> 50%

Turn Around / Cycle Times Reduced

100%

Audit / Process Traceability

Automated Document Solutions

Connecting formatting, quality control, and publishing into a streamlined regulatory workflow.

document-formatting-automation

Document Formatting Automation

Standardize Documents Against Regulatory and Corporate Requirements

Regulatory documents often involve hundreds of pages, multiple contributors, complex tables, figures, references, cross-references, and strict formatting requirements.

Manual formatting can result in inconsistent styles, incorrect pagination, broken links, misplaced content, table inconsistencies, and other technical issues that require repeated review and rework.

REGai’s Document Formatting Automation applies predefined regulatory and company internal rules to documents. The platform includes a library of more than 500 formatting rules and can automate common document-structure and layout activities.


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document-qc-automation

Document Quality Control Automation

Move From Manual Inspection to Automated QC

Formatting is only one part of submission readiness. Regulatory documents must also be checked for consistency, completeness, structure, references, terminology, values, tables, and compliance with defined quality standards.

Manual QC across large regulatory documents is time-consuming and can make it difficult to achieve consistent results across teams and submission programs.

REGai’s QC Automation solutions provide a library of 600+ document checks covering areas such as formatting, grammar, tables, layouts, Tables of Contents, bookmarks, hyperlinks, consistency, and regulatory requirements.


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regulatory-publishing-automation

Regulatory Publishing Automation

Transform Approved Documents Into Submission-Ready Output

Once content has been authored, formatted, and quality-checked, regulatory publishing brings the final pieces together.

Publishing teams often need to manage large volumes of Word and PDF files while validating document structure, hyperlinks, bookmarks, file naming, formatting, and eCTD-related requirements.

REGai’s publishing automation capabilities help streamline this final stage by applying automated validation and document-processing rules to prepare submission content efficiently. REGai supports publishing workflows using hundreds of automated rules for activities such as document formatting, tables, headers and footers, Tables of Contents, bookmarks, hyperlinks, file naming, and validation.

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One Connected Approach to Regulatory Document Operations

Instead of treating formatting, QC, and publishing as separate manual activities, organizations can create a connected workflow that identifies issues earlier, automates repetitive corrections, and supports consistent regulatory output.

Authoring Authoring
→
Formatting Formatting
→
Quality Control Quality Control
→
Remediation Remediation
→
Publishing Publishing
→
Submission-Ready Output Submission-Ready Output

DDi brings these capabilities together through an automation-driven approach:

prepare

Prepare

Apply regulatory and corporate formatting requirements consistently.
prepare

Check

Run automated QC across documents using extensive rule libraries.
fix

Fix

Automatically remediate eligible formatting and quality issues.
publish

Publish

Validate and prepare documents for regulatory publishing and submission.
Track

Track

Maintain a consistent, repeatable process across document workflows.

This approach allows organizations to shift from manual document inspection and correction toward a more standardized and automated regulatory publishing process.

Ready to Transform Regulatory Document Operations?

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Frequently Asked Questions

Common questions about REGai Regulatory Operations document automation solutions.

faq-question

What is REGai Regulatory Operations automation?

REGai is an automation platform designed for regulatory, medical writing, CMC, labeling, and publishing teams in life sciences. It connects document formatting, quality control (QC), and publishing into a streamlined workflow using rule-based automation and AI to produce submission-ready eCTD output.

faq-question

What key business outcomes can organizations achieve using REGai?

Organizations using REGai experience:

  • Over 70% reduction in manual document preparation effort
  • 65% lower operating costs
  • More than 50% decrease in turnaround and cycle times
  • 100% auditability and end-to-end process traceability
faq-question

How does REGai automate regulatory document formatting?

REGai standardizes complex documents against regulatory agency and internal corporate rule books. Utilizing a library of over 500 predefined formatting rules, it automatically corrects styles, pagination, tables, cross-references, and structural layouts across hundreds of pages.

faq-question

What checks are included in REGai’s Document Quality Control (QC) Automation?

REGai provides a library of more than 600 automated document checks. These cover grammar, terminology, layout consistency, Tables of Contents (TOC), bookmarks, hyperlinks, table values, and regulatory compliance requirements.

faq-question

How does REGai support regulatory publishing and eCTD preparation?

REGai automates final submission prep by managing Word and PDF files against eCTD requirements. It uses hundreds of automated processing rules to validate file naming, structure, headers/footers, bookmarks, and hyperlinks before submission.

faq-question

What is the end-to-end workflow supported by DDi’s REGai platform?

DDi connects the entire regulatory document life cycle into a 5-step automated workflow: Prepare (apply formatting) → Check (run automated QC) → Fix (remediate identified issues) → Publish (validate for submission) → Track (maintain process traceability).

The First Step

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