From vision to reality: the evolution of submission management
In 2022, LORENZ published a white paper predicting a significant shift in submission management and regulatory practices. We envisioned a future where the regulatory community would leverage digital transformation to streamline their regulatory processes, enhance collaboration, and improve patient outcomes. Fast forward to today where LORENZ is engaged with innovation proof of concepts such as project PRISM (PrecisionFDA Regulatory Information Service Module) and technology partnerships to further explore future possibilities. LORENZ's partnership with DNAnexus is at the forefront of this evolution.
A seamless digital transformation for regulatory submissions
DNAnexus and LORENZ are joining forces to explore the future of Trusted Regulatory Spaces‐secure, cloud-native environments that streamline regulatory submission validation and foster seamless collaboration between sponsors and health authorities.
Through this partnership, we aim to:
→ Enable collaborative submission validation for regulatory applications.→ Enhance real-time communication between sponsors and health authorities.
→ Provide secure private and shared workspaces to support interactive reviews.