Our team of experts specializes in pharmacovigilance, ensuring the safety and efficacy of your products through comprehensive monitoring, data analysis, and regulatory compliance. We are committed to maintaining the highest standards in patient safety and providing you with insightful reports and recommendations to enhance product performance.
All documents collected by the manufacturer for registration of medicine which are:
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PSMF No. (The pharmacovigilance system master file)
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RMP (Risk management plans) submission in the MOH in New Registration.
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(PSUR) A Periodic Safety Update Report submission for the Re-registration process.
– RMP aims for the risks of drugs to be evaluated at regular intervals or in response to the progress of post-marketing surveillance and pharmacovigilance activities to minimize the risks of drugs.
– Periodic safety update reports (PSUR) A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorization.
Pharmacovigilance services involve the systematic monitoring, assessment, and prevention of adverse effects or any other drug-related problems to ensure patient safety and the effective use of medications. These services collect and analyze data from various sources, including clinical trials, healthcare providers, and patient reports, to identify potential safety issues and inform regulatory actions. The ultimate goal is to enhance drug safety through proactive risk management, thereby protecting public health and improving therapeutic outcomes.