Inspection Readiness

Regulatory inspections and PV audits can be complex and demanding. At MedWatch Consulting, we help organizations prepare their pharmacovigilance (PV) systems and teams to confidently face inspections from authorities such as the FDA, EMA, and MHRA.

Our support includes gap analysis, remediation planning, audits, and tailored training to ensure your processes, documentation, and systems meet global regulatory standards. We also help prepare inspection-ready evidence, ensuring that all data and workflows are transparent, traceable, and fully compliant.

With our experience in multiple successful inspections, we provide both the technical and practical expertise to guide your team through every step — reducing risks and giving you confidence that your PV system is ready for scrutiny.

Gap analysis and remediation

Gap analysis and remediation

We identify PV system gaps and implement remediation to ensure full compliance.

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Audits and training

Audits and training

We conduct PV audits and deliver training to strengthen compliance and readiness.

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Documentation and evidence preparation

Documentation and evidence preparation

We prepare clear documentation and evidence to demonstrate PV compliance during inspections.

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System Implementation

System Implementation

Establishing and maintaining compliant pharmacovigilance and medical information systems.

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PV Alliance

PV Alliance

Where business development meets pharmacovigilance.

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Safety Operations

Safety Operations

Managing case processing, risk management, and reporting.

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Early Access Programs

Early Access Programs

Supporting the implementation of expanded access to treatments.

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