Our regulatory surveillance service is subscription-based where you determine the frequency of the requested reports and reviews.

As with all of our offerings, the items listed here are the base level where you can select what pieces work best for your budget and goals.

• Work with your compliance team to determine key elements for regulatory action identification
• Develop search mechanism for relevant 483 and warning letters and compile records
• Focus our search on the types of companies that closely reflect your own (i.e., compounding, med device, biologic)
• Categorize the regulatory findings (i.e., all observations, validation, quality systems, EM) to identify key systems
• Establish a customized cadence of reviews based on your needs (weekly, monthly)
• Provide a synopsis/report of trends and observations from relevant regulatory actions at defined frequency
• Lead review meetings with your staff to determine if identified observations represent a risk for them
• Maintain a surveillance log proposed actions to ensure gaps are being addressed proactively