Regulatory bodies mandate the sponsors/MAHs to submit safety information in applicable aggregate report formats and defined reporting timelines depending on the stage of product life cycle. These reports enable regulatory authorities, pharmaceutical companies, and other stakeholders to understand overall risk-benefit profile time to time. The reporting timelines, frequency, and type of aggregate reports vary with regulatory bodies worldwide.

Our team comprises seasoned pharmacovigilance professionals with extensive experience in analyzing adverse event data and generating actionable insights for compilation, medical review, quality review and submission to various regulatory bodies.

Stay ahead of regulatory requirements with our meticulously crafted aggregate reports that adhere to the latest guidelines and standards.