Adverse Event Reporting (AER) has been a requirement for dietary supplement manufacturers, packers and distributers in the United States since December 22, 2007. Companies are required under the Dietary Supplement and Nonprescription Drug Consumer Protection Act to report all serious adverse events (SAEs) to the FDA. Many companies do not have the in-house expertise to complete AERs and may not keep appropriate records for dietary supplements and non-prescription drugs to fulfill this obligation. dicentra has both the scientific and regulatory expertise to assist you in this area.
Our services in Adverse Event Reporting (AER) include:
- Adverse event evaluation and classification
- Guidance on how, when, and where to submit FDA Form 3500 and 3500A
- Preparation of adverse event case reports
- Record maintenance for serious and non-serious adverse events
- SOP review and generation for Call Center Representatives on completing AER form
- Creation of templates for Customer Complaints (for AER and/or quality complaints)
You can minimize your legal risks by having dicentra handle your Adverse Event Reporting.