Adverse Drug Event Reporting
Adverse Drug Event (ADE) Response & Reporting Support
Bio/pharmaceutical manufacturers and compounders alike are required to maintain written procedures for identifying, investigating, and reporting adverse drug events (ADEs) to the FDA and certain state agencies.
We ensure your team responds swiftly, documents correctly, and reports on time. From guiding investigations to preparing for regulatory scrutiny, we help you meet compliance requirements, avoid delays, and reduce risk when ADEs occur.
Why Choose Us?
Our consultants have extensive experience in assisting with reporting adverse events in a proper and timely manner to mitigate unnecessary regulatory backlash. We excel at assisting in report writing, investigating the event, and creating an action plan to prevent similar future events.
Your report must be submitted quickly, don’t wait too long to contact the right team to get you through this situation.
Our Approach
Event Discovery
Adverse Drug Event Report
Investigation Support
CAPA Plan
Remediation Implementation
Audit Preparation