Federal and State Requirements

SafetyCall can provide for turnkey regulatory reporting to all relevant State and Federal agencies, including:

• EPA: FIFRA 6(a)(2) mandatory reporting
• CPSC: TSCA and FHSA reporting and record keeping
• FDA: Drug and medical device mandatory reporting
• FDA: Dietary Supplements

Consumer Product Incident Database

The CPSC Consumer Product Incident Database and the Canada Consumer Product Safety Act are now active. For more information and to learn more about SafetyCall's reporting services click on the links below:

• U.S. Consumer Product Safety Commission (CPSC)
• Canada Consumer Product Safety Act (CCPSA)

Unparalleled experience in EPA, FIFRA 6(a)(2) reporting

When the joint Industry/EPA committee on 6(a)(2) reporting met to design a national voluntary incident reporting format SafetyCall experts helped to coordinate the process and authored the guidance document. With SafetyCall’s expertise you will always be on top of any EPA reporting requirements.

Pharmacovigilance Services

24/7 SafetyCall Pharmacovigilance Services capture adverse event data regarding drugs or medical devices and provide a completed 3500A form for expedited report submission to the FDA. SafetyCall pharmacists can provide appropriate medical and drug safety information to help address or resolve potential adverse events.

Periodic Safety Update Reports

In addition to expedited report surveillance, SafetyCall provides services for completion of Periodic Safety Update Reports (PSURs) for NDA/ANDA products, which include:

• Completed 3500A forms for PSUR submissions.
• Index of adverse events previously reported as 15-day alert reports during the reporting period.
• Index of adverse events not meeting the 15-day alert reporting requirements during the reporting period.
• Tabulation by body system of all adverse event terms (15-day and Periodic Reports), and occurrence counts.