Pharmacovigilance
Pharmacovigilance is a critical component of drug safety management, aimed at identifying, assessing, and preventing adverse drug reactions (ADRs) to ensure the ongoing safety and efficacy of pharmaceutical products. Equilab's Pharmacovigilance services are designed to provide comprehensive support for the proactive monitoring and management of drug safety throughout the clinical trial process.
Furthermore, we assist in the submission of SUSAR reports to investigators and regulatory authorities. We ensure prompt notification of serious adverse events for rapid assessment and action. Equilab complies with reporting requirements, submits SUSAR reports timely, and upholds transparency in drug safety monitoring.
SUSAR Report to Investigator and Regulatory Authorities (RA)
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Equilab’s Pharmacovigilance (PV) team collaborates efficiently with sponsors and regulatory authorities to manage pharmacovigilance reports. We provide support throughout the pharmacovigilance lifecycle, from data collection to risk management and regulatory reporting. We ensure prompt and accurate report processing, proactive risk mitigation, and regulatory compliance. Our open communication promotes safety and vigilance in drug development and clinical research.