A Complete Submission Publishing Solution for Life Sciences 2022 Demo

This video explores PhlexSubmission, a comprehensive solution for electronic regulatory submissions (eCTD, NeeS, VNeeS) in the life sciences. The speaker demonstrates how the platform streamlines the entire submission lifecycle, from document management and compilation to publishing and validation. Key themes include automation for efficiency, ensuring regulatory compliance, global reach, and user guidance. Throughout the video, the presenter highlights features such as automated eCTD tree creation, intelligent document auto-compilation based on metadata, an integrated 21 CFR Part 11 compliant document management system (Flex DMS), and built-in compliance checks for hyperlinks and PDF properties, often with automatic resolution. The system supports incremental test publishing with integrated FDA eCTD validation (Lorenz validator) and productive publishing, ensuring regulatory adherence. PhlexSubmission also offers capabilities for managing document versions, reusing submissions across different regions, and is delivered as a private SaaS solution, emphasizing global accessibility and unlimited publishing. The "Vera" virtual assistant guides users through complex processes, enhancing user experience and efficiency.

Key Takeaways:

• End-to-End Regulatory Submission Management: PhlexSubmission provides a complete solution covering document management (21 CFR Part 11 compliant), eCTD compilation, publishing, and validation, which is crucial for pharmaceutical and life sciences companies navigating complex regulatory landscapes.
• Automation for Efficiency and Compliance: The platform leverages automation for eCTD tree creation, metadata-driven document auto-compilation, and automatic detection/replacement of document versions, significantly reducing manual effort and potential errors in regulatory submissions.
• Global Scalability and Reusability: The system supports managing submissions for multiple health authorities worldwide and allows for easy copying and adaptation of submissions across different regions, enhancing global regulatory strategy and operational efficiency for multi-national life sciences clients.
• User-Centric Design with AI-Assistance: Features like the personalized user dashboard and "Vera," a virtual electronic regulatory assistant, guide users through complex tasks, making the submission process more accessible and reducing the learning curve, demonstrating a practical application of intelligent assistance in a regulated environment.
• SaaS Model for Accessibility and Flexibility: Delivered as a private SaaS solution, PhlexSubmission offers web-browser accessibility from anywhere, unlimited test and productive publishing, and readiness for eCTD version 4, providing a flexible and future-proof solution that resonates with modern software development practices.