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:

• compilation of aggregate reports as per the regulatory requirements on a global basis
• publishing of reports and preparation of submission packages (electronic common technical document [eCTD] format) and
• electronic submissions to various regulatory authorities via submission portals.

The APCER Aggregate Reporting team will help you create and submit:

• Periodic benefit-risk evaluation reports (PBRERs)
• Periodic safety update reports (PSURs)
• Periodic adverse drug experience reports (PADERs)
• Addendum to clinical overview (ADCO) for renewal
• Clinical expert statements (CESs)
• Summary bridging reports (SBRs)
• PSUR addendum reports (ARs)
• Development safety update report (DSUR)
• Annual safety report (ASR)
• Annual investigational new drug (IND) safety report
• Expert reports for renewals
• Safety assessment reports