Meet MARIE: Writing the Dossier

Join us for Meet MARIE: Writing the Dossier, an exclusive session demonstrating how BIOVIA’s agentic AI Virtual Companion revolutionizes regulatory content authoring.

Key Takeaways:

• Data-Driven Template Automation: See how MARIE dynamically pulls structured R&D, analytical, and manufacturing data directly into standardized regulatory templates for CMC dossiers, APQRs, and technical summaries.
• Streamlined Document Assembly: Learn how natural-language interactions allow authors to generate multi-section submission drafts, complex data tables, and cross-referenced reports at AI speed.
• Human-in-the-Loop Integrity: Understand how MARIE explicitly flags agent-generated text and calculations for expert human review, ensuring absolute accuracy and regulatory compliance.
• End-to-End Traceability & Audit Trails: Explore how every data point, reference, and document version generated by MARIE retains full lineage back to the original source of truth on the 3DEXPERIENCE platform.

Who Should Attend?

• Regulatory Affairs Specialists & Authors looking to compress authoring timelines and eliminate manual copy-pasting.
• CMC & Quality Assurance Leads seeking to automate APQRs and ensure seamless data alignment between R&D and manufacturing.
• Technical Writers interested in leveraging structured data templates and AI co-authoring tools.
• R&D Informatics & IT Directors evaluating solutions to connect scientific data repositories with downstream regulatory publishing.