High-Quality Postmarketing Report Writing
Within aggregate safety reports, safety data from relevant sources are periodically reviewed and assessed for patients’ safety and well-being.
At ProPharma Group, our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We have extensive knowledge in pharmacovigilance and aggregate safety report writing, and practical experience from the pharmaceutical industry, regulatory authorities, and academic settings. We can support you with advice in aggregate safety data analyses and in overall benefit-risk assessments.
Aggregate Safety Report Services and Expertise
Our full Aggregate Safety Report services include planning, time management, data requests, writing, quality control, strategic advice, communication, and evaluation. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as the Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).