Aggregate Reporting
Regulatory authorities require sponsors and Marketing Authorization Holders (MAHs) to submit safety information in standardized aggregate report formats within specific timelines based on the product’s lifecycle stage. These reports play a vital role in assessing and communicating a product’s evolving risk–benefit profile to regulators, pharmaceutical companies, and other stakeholders.
At Pharmazone, our team of experienced pharmacovigilance professionals specializes in analyzing adverse event data, deriving actionable insights, and ensuring accurate compilation, medical review, quality assurance, and timely submission to global regulatory agencies.
Stay ahead of regulatory expectations with our expertly prepared aggregate reports, designed to meet international standards and maintain full compliance.
Pharmazone Project Highlights
Development Safety Update Report (DSUR)
Comprehensive annual reports providing safety data for drugs under clinical development to ensure subject safety.
Periodic Benefit-Risk Evaluation Report (PBRER)
Evaluates the overall benefit-risk balance of an approved product throughout its lifecycle.
Periodic Safety Update Report (PSUR)
Summarizes global safety data for marketed products to maintain ongoing regulatory compliance.
Periodic Adverse Drug Experience Report (PADER)
Provides cumulative safety information for drugs approved in the U.S., submitted to the FDA.
Annual Investigational New Drug (IND) Safety Report
Details yearly safety findings from clinical trials conducted under IND applications.
Annual Safety Report (ASR)
Consolidates product safety information annually to ensure patient protection and compliance with local regulatory requirements.
