Pharmacovigilance services
Pharmacovigilance (PV) is the process of monitoring the safety of medicines. Marketing Authorization Holders (MAHs) have a legal obligation to set up and maintain a Pharmacovigilance system. Our team possesses the appropriate knowledge and experience related to the detection, assessment, understanding and prevention of adverse effects. SciencePharma has developed the full pharmacovigilance system as described in Good Pharmacovigilance Practices (GVP), which is compliant with EU requirements, so we provide full pharmacovigilance services. We offer the implementation of our pharmacovigilance system to our Clients including all quality aspects of full system.
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Analysis and management of case reports derived from various sources
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Preparation of PSURs
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Preparation of RMP
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Monitoring of adverse events (AEs) for pharmaceutical companies