Documentation and Evidence Preparation

Well-organized documentation is a cornerstone of any inspection-ready pharmacovigilance (PV) system. At MedWatch Consulting, we help you prepare, review, and maintain the evidence needed to demonstrate compliance during regulatory inspections and audits.

Our services include the creation and alignment of Standard Operating Procedures (SOPs), process maps, safety reports, training records, and quality documentation. We ensure all materials are clear, consistent, and traceable, providing inspectors with a transparent view of your safety operations.

With our structured approach to documentation and evidence preparation, your team will enter inspections with confidence, backed by a complete, compliant, and audit-ready record of activities.

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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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