ADVERSE EVENT REPORTING & COMPLIANCE

Marker is Your Event Reporting Resource

The FDA takes adverse event reporting obligations seriously and do not view them as technical regulatory requirements. FDA regulatory lapses can create meaningful risk for a company, which is why the Marker Group supports our clients by providing adverse event reporting and compliance solutions.

We provide timely and complete adverse event regulatory reports involving regulated products. We can also implement trend analysis and benchmarking reviews. The Marker Group’s experienced, medically trained staff can triage as well as provide relevant adverse event information.

For a variety of industries, the Marker Group provides 24/7/365 adverse event management, incident documentation, and health and regulatory compliance for our clients.

ADVERSE EVENT COMPLIANCE MADE EASY

The Marker Group is fully trained on Adverse Event Reporting requirements and timelines. We understand the importance of getting substantive records delivered to your patient safety and pharmacovigilance teams so that FDA timelines can be met. Our established process for ensuring timely and complete delivery in your preferred format will eliminate the need for multi-party involvement and potential late reports.

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