Everyone wants to know the latest news from the FDA, but it’s always hard finding the time to do the searches, and more importantly, gap assess against your firm’s current processes/systems.
Don’t hire to this surveillance project, outsource it!
Our Regulatory Surveillance team will:
1. Work with your compliance team to determine key elements for regulatory action identification
2. Develop search mechanism for relevant 483 and warning letters and compile records
3. Focus our search on the types of companies that closely reflect your own (i.e., compounding, med device, biologic)
4. Categorize the regulatory findings (i.e., all observations, validation, quality systems, EM) to identify key systems
5. Establish a customized cadence of reviews based on your needs (weekly, monthly)
6. Provide a synopsis/report of trends and observations from relevant regulatory actions at defined frequency
7. Lead the review meetings with your staff to determine if identified observations represent a risk for your firm
8. Maintain a surveillance log with client proposed actions to make sure gaps are being addressed proactively
Don’t respond to the 483, prevent the 483!
Cost effective packages available for customization to any budget
Stay ready so you don’t have to get ready!
