CMC Authoring
Solutions

In today’s rapidly evolving product development environment, the need for accurate, compliant, and high-quality CMC documentation has never been greater.

DDi’s CMC Authoring Solutions use advanced AI technology to modernize traditionally manual and time-consuming documentation processes into a faster, smarter, and highly efficient workflow.

At the center of our solution are the Authoring Agent and QC Agent. These intelligent agents act as digital collaborators for your CMC teams. The Authoring Agent helps generate high-quality first drafts, context-driven content, and concise summaries. The QC Agent automates comprehensive quality checks across content, data, and document formatting.

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Authoring Automation

Modern CMC documentation requires more than templates. It requires intelligence. Our Authoring Agent
creates draft sections for human review, allowing teams to spend less time starting from scratch and more time
refining technical content and strategic messaging.

By integrating AI-powered writing agents, we simplify the most resource-intensive parts of document development

Automated Summarization

Generate summaries of technical reports, product changes, manufacturing data, and regulatory updates instantly, ensuring critical insights are never missed.

Context-Aware Assistance

Receive real-time AI recommendations to enhance existing content, improve clarity, and maintain consistency across documents.

Data-to-Text Generation

Transform structured manufacturing and quality data into well-written document sections, reducing repetitive manual drafting..

Automating Quality Control (QC)

Even minor errors in CMC documentation can delay approvals and submissions. Traditional QC often depends on
multiple manual review cycles, increasing timelines and effort.

DDi’s QC Agent brings speed, consistency, and objective precision to document review.

Consistency Checks

Ensure terminology, values, abbreviations, and references remain consistent across lengthy dossiers and multiple files.

Compliance Verification

Automatically compare content against global regulatory expectations and internal quality standards.

Faster Review Cycles

Identify issues early and recommend corrections automatically, helping teams achieve right-first-time submissions.

Formatting Automation

Final document formatting often becomes a major bottleneck before submission. DDi’s Formatting Agent
removes the burden of manual styling and layout corrections.

Global Standard Alignment

Automatically format documents to meet submission standards for agencies such as FDA, EMA, and other global authorities.

Template Automation

Apply company templates, branding rules, headers, footers, tables, and styles instantly with precision.

Error-Free Output

Detect and correct layout issues that are commonly missed during manual checks, delivering polished and submission-ready documents faster.

Ready to Transform Your CMC Documentation?

Do not let manual processes slow down your product timelines. Experience the next generation of CMC document automation with DDi’s Agentic AI solutions.

Frequently Asked Questions

What are DDi’s CMC Authoring Solutions?

DDi’s CMC Authoring Solutions utilize advanced AI technology - specifically intelligent Authoring and QC Agents - to modernize manual Chemistry, Manufacturing, and Controls (CMC) documentation workflows into faster, compliant, and submission-ready processes.

How does the AI Authoring Agent assist in CMC document creation?

The Authoring Agent acts as a digital collaborator by generating initial high-quality drafts, providing context-aware content recommendations, creating automated technical summaries, and performing data-to-text generation from structured manufacturing data.

How does the QC Agent improve CMC compliance and speed up reviews?

The QC Agent automates comprehensive quality control checks across data, content, and formatting. It performs multi-file consistency verification, checks content against FDA and EMA regulatory standards, and flags discrepancies early to ensure right-first-time submission dossiers.

Does DDi’s solution automate CMC document formatting?

Yes. DDi includes a dedicated Formatting Agent that automatically aligns documents with global submission standards (FDA, EMA, etc.), applies corporate template styling, headers, footers, and tables, and corrects layout errors prior to regulatory filing.

What are the primary operational benefits of AI-powered CMC authoring?

By deploying AI authoring and automated QC, life sciences teams reduce manual drafting time, eliminate repetitive formatting bottlenecks, maintain strict terminology consistency, minimize regulatory submission delays, and lower overall operational risks.

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CMC Authoring
Solutions