Comprehensive Pharmacovigilance System Setup and SOP Development
At Soterius, we specialize in setting up robust pharmacovigilance (PV) systems tailored to your organization’s unique needs, ensuring compliance with global regulatory requirements. Our experienced team expertly authors customized Standard Operating Procedures (SOPs), clearly defining processes for safety monitoring, reporting, risk management, and quality assurance. By establishing a comprehensive and structured PV system, we empower your organization to efficiently meet regulatory expectations while safeguarding patient safety.
Expertise in Authoring and Maintaining Pharmacovigilance System Master Files (PSMFs)
Our pharmacovigilance experts meticulously author and maintain Pharmacovigilance System Master Files (PSMFs), ensuring accurate, up-to-date documentation of your organization’s safety system. We provide ongoing maintenance and periodic updates, reflecting organizational changes, regulatory developments, and evolving safety practices. Our proactive approach ensures your PSMF consistently meets global regulatory standards, enhancing your organization’s readiness for regulatory scrutiny.
