Adverse Events Management

Handling consumer complaints and adverse event reports requires more than just paperwork — it requires a system for tracking, responding, and reporting issues quickly and accurately.

USAgentPros provides full-service Adverse Events Management to help you protect your customers and stay FDA compliant.

Registrar’s Adverse Events Management (AEM) software is a turnkey solution to manage the entire Adverse Event process from consumer intake to investigation to FDA reporting and records storage.

What We Do

  • Establish systems to capture adverse event data from customers
  • Evaluate reports to determine if FDA notification is required
  • Submit mandatory reports to FDA on your behalf
  • Maintain detailed records for future inspections
  • Provide corrective action guidance when patterns emerge

Why Adverse Event Management Matters

Without a clear process, companies risk:

  • Missed reporting deadlines
  • FDA enforcement or warning letters
  • Loss of consumer trust if issues go unaddressed

With USAgentPros, you’ll have confidence that every event is documented, reviewed, and reported correctly.

Why Work With USAgentPros?

Dedicated Compliance Pro – A single point of contact for your case management
Fast Turnarounds – Keep your company compliant and responsive
100% Money-Back Guarantee – Built-in confidence with every service
Competitive Pricing – Practical, cost-effective solutions

Simplify Adverse Event Management

Let USAgentPros create a structured, compliant process for managing and reporting adverse events.