Adverse Events Reporting

...an experienced partner in meeting

complex reporting requirements.

ADDITIONAL SERVICES

Home | Services | Qualifications | Markets We Serve

Management Team | News Room | Contact Us | Pet Poison Helpline™

Call today for more information! (866) 327-7282

ADVERSE EVENT REGULATORY REPORTING

Federal and State Requirements

SafetyCall™ can provide assistance 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

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

SafetyCall experts “wrote the book” on 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 coordinate the process and authored the guidance document. With SafetyCall expertise, you will always be on top of any EPA reporting requirements.

Pharmacovigilance Services

24/7 SafetyCall Pharmacovigilance Services captures adverse event data regarding drugs or medical devices and provides a completed form 3500A 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.

Adverse Event Reporting Legislative Update; June 21, 2006

Adverse drug reaction and poison control center