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PHARMACOVIGILANCE

 PHARMACOVIGILANCE

Our in-house team possess extensive expertise to assist pharmaceutical and biotech companies in the selection, implementation, integration, auditing, and optimization of pharmacovigilance systems.

Sustaining a pharmacovigilance (PV) system that aligns with regulatory standards and is tailored to your organization poses a formidable challenge. Drawing on years of practical experience and collaborating closely with all stakeholders, we assess your pharmacovigilance system, identify gaps, and design streamlined process frameworks that align with your organization’s requirements and regulatory standards.

We offer practical assistance in documenting various components and processes of the pharmacovigilance system, including Standard Operating Procedures (SOPs) and Work Instructions. Furthermore, we aid in maintaining a compliant Pharmacovigilance System Master File (PSMF) and provide guidance when considering the outsourcing of specific pharmacovigilance system components.