Periodic aggregate reporting to regulatory authorities throughout the drug life cycle
During the clinical development and for the entire life cycle of the drug, the sponsors/MAHs must submit the safety information to the regulatory authorities within the defined time intervals. This information will help companies and the regulators assess the overall risk-benefit profile of the product on a periodic basis. These timelines, frequency, and type of periodic reports vary by country.
Our team of experts ensures timely submission of high-quality periodic reports, safety summary updates, and risk assessment documents in the proper format with the appropriate clinical content.
The team is experienced in:
The APCER Aggregate Reporting team will help you create and submit: