Comprehensive Aggregate Reports Authoring Services
Soterius specializes in expertly authoring and managing the preparation, review, and timely submission of critical pharmacovigilance aggregate reports, including Periodic Safety Update Reports (PSURs), Aggregate Safety Reports (ASRs), and Periodic Adverse Drug Experience Reports (PADERs). Our dedicated medical writing team delivers thorough, accurate, and compliant reports aligned with global standards, including ICH E2E guidelines, Good Pharmacovigilance Practices (GVP), and specific regional regulatory requirements.
Physician-Led Expert Teams for Enhanced Accuracy
Our physician-led teams are strategically organized based on therapeutic area expertise and report complexity, ensuring precise analysis and high-quality reporting. This specialized approach enables in-depth, contextually relevant safety evaluations, empowering sponsors to effectively communicate safety profiles to regulatory authorities and stakeholders. By providing precise data interpretation and rigorous compliance, we strengthen regulatory confidence and patient safety.
