Aggregate Safety Reports

PVCON delivers high-quality aggregate safety report writing services including PSURs, PBRERs, PADERs, and DSURs that meet the requirements of the EMA, FDA, and other global regulatory authorities. Our medical writers combine scientific expertise with deep regulatory knowledge to produce reports that accurately characterize the evolving benefit-risk profile of your medicinal products.

Our aggregate reporting services encompass comprehensive safety data analysis, preparation of line listings and summary tabulations, critical evaluation of new safety information, and detailed benefit-risk assessments. We ensure all reports are prepared in compliance with ICH E2C(R2) guidelines, EU GVP Module VII, and applicable local regulatory requirements.

PVCON manages the full aggregate report lifecycle — from data lock point planning and safety data retrieval through authoring, quality review, and submission-ready finalization. Our systematic approach ensures consistency, scientific accuracy, and on-time delivery, helping your organization maintain uninterrupted regulatory compliance across all markets where your products are authorized.