Introduction:

The FDA’s transition to ESG NextGen is set to take effect soon, requiring all users to adapt to the new system. As part of this upgrade, there will be a submission blackout from April 12th-14th, 2025, during which no electronic submissions will be accepted.

To ensure compliance, PharSafer will hold all submissions during this period, ensuring that any expedited reports due within this timeframe are submitted in advance.

Our team has also implemented a structured project plan to manage this transition smoothly, minimising disruption whilst ensuring full compliance.

Our Approach Includes:

• System Updates: Verifying user access and aligning internal processes with the new submission framework.
• FDA Testing & Validation: Participating in controlled test submissions from March 31st – April 9th, 2025, to confirm data integrity, system functionality, and legacy data migration.
• Regulatory Compliance: Maintaining full documentation of the transition for audit readiness.

Key Client Information:

• Submission Freeze: No electronic submissions will be processed from April 12th-14th, 2025.
• System Validation: PharSafer is working directly with the FDA to confirm successful data transfer and submission functionality.
• Ongoing Updates: We will continue to keep you informed throughout this transition.

PharSafer is committed to supporting our clients during this transition.

If you have any questions or require further guidance, please contact us directly: enquiries@pharsafer.com