Unlocking a legacy of proficiency: Our adept team boasts substantial experience in crafting comprehensive aggregate reports. Delve into our journey through the snapshots below:
Soterius has an experienced team that can support
sponsor in the following activities relevant to annual/ semi-annual aggregate reports:
Preparation, compilation, authoring, publishing and distribution of reports to ensure timely submission of the PBRERs as per applicable regulatory requirements.
Cumulative review of ICSRs/SAEs to be included in the periodic reports.
Line listing generation and review of reportrelated outputs from the safety database.
Inputs for generation of customized reports and line listings from the safety database.
Sales data generation and publishing in aggregate reports, where required.
Quality control and compliance tracking for report outputs, draft and final reports and submission data.
Reviewing and taking action on the assessment report conclusions received from the regulatory agencies, as required.
Provide support in responding to any post submission regulatory authority requests.
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