Pharmacovigilance

Ensuring patient safety is paramount in drug development and post-marketing. ABS Clinical Solutions provides robust pharmacovigilance services, offering comprehensive drug safety monitoring and adverse event reporting to meet global regulatory requirements and safeguard public health. Our pharmacovigilance team is equipped to handle all aspects of safety management, including adverse event (AE) and serious adverse event (SAE) processing, causality assessment, expedited reporting to regulatory authorities, and aggregate report writing (e.g., PSURs, DSURs). We utilize validated safety databases and adhere to international pharmacovigilance guidelines. We offer a proactive approach to risk management, including signal detection, risk-benefit assessment, and development of Risk Management Plans (RMPs). Our services extend to post-marketing surveillance, ensuring continuous monitoring of drug safety throughout the product lifecycle. Partner with us to establish a robust pharmacovigilance system that protects patients and ensures regulatory compliance.