Gap Analysis and Remediation

A thorough gap analysis is the first step in ensuring your pharmacovigilance (PV) system is ready for inspection. At MedWatch Consulting, we assess your existing processes, databases, and documentation to identify areas where compliance or efficiency may be at risk.

Once gaps are identified, we develop tailored remediation plans that address deficiencies, strengthen compliance, and align your PV system with global regulatory standards such as FDA, EMA, and ICH guidelines. Our approach ensures both short-term fixes and long-term improvements.

With clear recommendations and practical implementation support, we help your organization build a robust, audit-ready PV system that minimizes risk and maximizes operational performance.

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