News

DDi, a focused technology partner for the life sciences industry, today announced enhanced document operations and quality control capabilities for REGai, its specialized automation platform. Purpose-built for BioPharma and Medical Device organizations, REGai automates technical document workflows, document QC, publishing/formatting, and compliance checking to streamline Document activities

Life sciences teams (Regulatory, Clinical, Labeling, CMC) handle higher volumes of technical documents, and stricter health authority standards. Manual quality reviews and formatting fixes consume critical staff hours, creating process bottlenecks and increasing operational costs. REGai addresses these challenges by automating document operations across different business functions.

Advanced Document Operations Features:

• Expanded Quality Control Library: Integrates an enhanced format and QC check library containing over 600 pre-built rules for BioPharma and Medical Device technical files, cutting manual review effort by over 80 percent.
• Automated Document Formatting/Publishing: Applies 400 plus automated rules to fix table structures, headers, footers, tables of contents, bookmarks, and hyperlinks across Word and PDF files. This helps both Authors/Writers and Reg Ops teams
• Direct Error Remediation: Uses built-in automated remediation features to correct formatting errors directly within documents rather than returning files to authors.
• Country Readiness: Converts raw technical documents into submission-ready or company-specific rules ready documents in minutes while maintaining strict compliance.

“Managing technical document quality control should never become a bottleneck for global submissions,” said a DDi spokesperson Mahesh Malneedi. “By expanding our document format and QC check library, REGai eliminates repetitive manual formatting work, helping regulatory teams deliver fully compliant dossiers much faster.”

The system integrates directly with existing enterprise content repositories, enabling life science companies to enforce document consistency, improve data integrity, and accelerate cycle times as well as TAT.

Explore REGai Automation & Agentic AI platform, visit https://www.ddismart.com/regai-automation-and-agentic-ai-platform/

About DDi

DDi is a prominent technology partner providing clinical development, regulatory affairs, and compliance software solutions for the life sciences industry. Combining deep domain expertise with advanced software automation, DDi helps pharmaceutical, biotechnology, and medical device companies streamline operational processes, maintain audit readiness, and accelerate global market access.