Designing a fully functional and regulatory compliant pharmacovigilance system is paramount to any organization's drug safety success.
A Pharmacovigilance System Master File (PSMF) is required in many countries to be a Marketing Authorization Holder. The PSMF needs to be available for inspections and/or audits at all times. Required components varies in geographic regions worldwide.
The QMS is fundamental to all aspects of pharmacovigilance. In addition to building your QMS, we can provide full Quality Management System reviews. If your organization has recently finished an inspection or audit, our QMS services focus on corrective and preventative actions (CAPA) to meet any and all findings from audits or inspections. CAPA(s) are provided, with follow up until positive corrections are documented and completed.
Standard Operating Procedures (SOP) describe the critical processes within your pharmacovigilance system. At iVigee, we may review your existing SOPs, develop new SOPs, or perform a batch review for multiple/all SOPs in place impacted by new regulations.
Review of existing PV processes can make way for positive changes with dramatic increases in efficiency.Learn more
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