FDA Essentials

Serious Adverse Events Reporting Service

We can set up a dedicated phone line for OTC drugs, Cosmetics, or Dietary Supplement adverse events reporting. We can even receive the reports and file them with FDA on your behalf. Call us today!

Per Facility

Description

We forward every call (“Event”), including audio files and transcripts. For each Event, we provide a written evaluation regarding whether the Event is a “Serious Adverse Event” subject to FDA reporting. Upon request, we will file the required FDA Report.

Additional information

call_for_quote_btn

yes

×

U.S. Regulations Require All Food Facilities (E.G., That Manufacture, Process, Pack, Or Hold Food, Beverages, Or Dietary Supplements For And Food Facilities Located Outside The United States Must Designate A U.S. Agent.

$499 Per Facility
×