Postmarketing Report Writing

We ensure compliance with relevant regulations for aggregate safety reports and aggregate safety report writing. Our experience with authorities and industry helps us support you in aggregate safety data analyses and in overall benefit-risk assessments.

Aggregate Safety Report Services

We provide full Aggregate Safety Report services including planning, time management, data requests, writing, quality control, strategic advice, communication, and evaluation. We evaluate data and generate required periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).

Managing Legislation Requirements

Requirements and responsibilities of an EU QPPV are specified in EU legislation, while LPPVs are subject to their own national legislation. We help you through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies. We help offer you services accommodating your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.