Many sources contribute to the formation of the safety reports such as observational studies, clinical and non-clinical data, spontaneous reports, etc. The inflexible regulations and complexity of the report preparation have made aggregate reporting a major challenge for Marketing Authorization Holders. Also based on their status MAHs have to prepare different types of reports such as Development safety update report (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Periodic safety update report (PSUR), Addendum to the clinical overview (ACO), Canadian Annual Summary Reports (CASR), Pre-approval & Post-approval aggregate safety reports, Periodic Adverse Drug Experience Reports (PADER), etc. Aggregate reporting is a huge responsibility that takes a lot of effort, so it is essential to have an experienced partner by your side. Each of these reports has its purpose and helps in making the drug safer for the patients. Pre-approval reports usually contain all the nonclinical and safety information related to the drug in clinical trials. Post-approval reports consist of the complete summary of the company’s core safety details for the products that are being marketed.