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
As a full-service pharmacovigilance provider, we specialize in navigating the complex regulatory landscape. Our advanced systems are designed to continuously evaluate the effects of evolving regulations on our processes, ensuring ongoing compliance and readiness for inspections.