PDC offers comprehensive pharmacovigilance solutions designed to ensure patient safety, regulatory compliance, and effective risk management throughout the pharmaceutical product lifecycle. Our dedicated pharmacovigilance team combines deep expertise with state-of-the-art systems to proactively address safety concerns and regulatory requirements globally.
Our pharmacovigilance services include:
- Case Processing: Efficient and accurate management of adverse event reports, timely submission of safety data to regulatory authorities, and rigorous quality assurance processes to maintain data integrity.
- Signal Detection: Early identification of potential safety risks through advanced analytical methods, expert evaluation of emerging safety signals for timely action, and implementation of strategic risk minimization measures.
- Aggregate Reporting: Preparation and submission of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other global safety reports, compliance with regional and international regulatory standards, and transparent and structured reporting processes.
- Regulatory Submissions: Comprehensive management of safety-related regulatory documentation, expert guidance and communication with regulatory authorities, and timely submission ensuring smooth regulatory interactions.
At PDC, we proactively safeguard patient welfare by continuously monitoring product safety profiles and ensuring regulatory compliance. Our integrated approach and regional expertise enable us to effectively manage pharmacovigilance processes, delivering peace of mind and robust safety solutions for our clients.
