At Dr. Mwiko Health Solutions Ltd, we provide comprehensive aggregate safety reporting services that ensure continuous oversight of your product’s safety profile throughout its lifecycle. Our experienced pharmacovigilance professionals prepare, review, and submit all required aggregate reports in compliance with global regulatory guidelines, helping you meet
obligations efficiently while maintaining scientific integrity and consistency across submissions.
Our Aggregate Reporting Services Include:
- Periodic Safety Update Reports (PSURs) and Periodic Benefit–Risk Evaluation Reports (PBRERs) prepared in accordance with ICH E2C(R2) and GVP Module VII
- Development Safety Update Reports (DSURs) to support ongoing clinical trials and regulatory submissions
- Addendum to Clinical Overview (ACO) and Annual Safety Reports (ASRs) for national and international submissions
- Signal detection integration within aggregate reports to ensure proactive identification of emerging safety trends
- Medical and scientific writing support for narratives, benefit–risk summaries, and safety conclusions
- Regulatory submission and compliance management, including scheduling, version control, and authority communications
- Safety data integration and analysis from spontaneous reports, clinical studies, and literature sources to provide a comprehensive overview of product safety
