The TopQ USA team has highly trained professionals and physicians who are fully committed to establishing and maintaining a close business relationship with our clients. We will develop a customized plan to meet your pharmacovigilance needs in a professional, efficient, and cost-effective manner.
US FDA required adverse event reporting -- PADER, ICSR
Standard/non-standard medical inquiries, signal detection, literature search & inspection support
Expert consultation for your pharmacovigilance needs
Periodic Adverse Drug Experience Report (PADER) is a part of post-cumulative safety reports which need to be submitted to the United States Food and Drug Administration (USFDA). The main purpose of a PADER is to update and evaluate a medicine’s global data and provide information about drug safety. For the initial three years, the company needs to submit the report quarterly and, thereafter, annually upon obtaining approval from the FDA.
The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
Medical Information (MI) is the collection, handling and dissemination of information on medications, and their safe and correct use.
Signal detection in pharmacovigilance involves looking at the adverse reaction data for patterns that suggest new safety information.
Our business consulting services include:
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