DIA RSIDM 2025

Session 8, Track 1: Regulatory Submission Revolution: Insights into eCTD 4.0, Agile Governance & AI-Driven Document Migration
Session Chair: Shenqi (Handsome) Ji, Regional Publishing Lead, Asia, Global Regulatory Operations, Pfizer, China

CoAuthor

Regulatory writing technology needs to be smarter, user-friendly, and collaborative—and CoAuthor delivers. It streamlines the process with fast template selection, structured content authoring, and generative AI within Microsoft Word.

• Spend 50% less time formatting your document by applying your style guides to more than 275 eCTD compliant templates.
• Reuse any portion of your writing, from a compound name to complete paragraphs on mechanism of action, across all your documents.
• Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation

GlobalSubmit eCTD Platform

GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.

• Create submissions that conform to any or all of 9 health authorities’ required structure, XML, and validation report.
• Review eCTD submissions across stakeholders prior to submitting

• Automated Writing Without the Compromise
• GlobalSubmit™ eCTD Platform Factsheet
• Regulatory Operations Factsheet
• eCTD Authoring Templates Factsheet
• GlobalSubmit™ eCTD Software Webpage
• Regulatory Operations Webpage
• 10 Things to Know About eCTD 4.0
• Watch our 300 submissions milestone video
• Top Lessons Learned from 300 Regulatory Submissions

• Regulatory Submission Leadership Webpage