Due Diligence Audit in Pharmacovigilance

Ensuring Compliance. Mitigating Risk. Protecting Patient Safety

In today’s highly regulated life sciences environment, pharmacovigilance (PV) due diligence audits are critical for evaluating compliance, operational readiness, and risk exposure before business partnerships, acquisitions, licensing, or outsourcing arrangements.

CMPV Consultancy LLP delivers independent, risk-based Pharmacovigilance Due Diligence Audits to help organizations make informed decisions with confidence.

Why Pharmacovigilance Due Diligence Matters

A weak or non-compliant PV system can result in:

Regulatory findings and warning letters
Product approval delays or license withdrawal
Reputational and financial risk
Compromised patient safety

Our audits provide early visibility of gaps, risks, and remediation priorities—before they impact your business.

Our Pharmacovigilance Due Diligence Audit Services

CMPV’s due diligence audits are designed to assess the maturity, compliance, and sustainability of PV systems across the product lifecycle.

Audit Coverage Includes:

Global & Local PV System Assessment
Compliance with ICH, GVP, CDSCO, US FDA & EMA requirements
Safety Governance & QMS Evaluation
Case Processing & Reporting (ICSRs, SUSARs)
Signal Detection & Risk Management
Vendor & Partner Oversight
Data Integrity & Inspection Readiness
SOPs, Training & Documentation Review

Our Audit Approach

✔ Pre-Audit Risk Assessment
✔ Document & System Review
✔ Remote or On-Site Audit Execution
✔ Gap & Risk Categorization (Critical/Major/Minor)
✔ Actionable CAPA Recommendations
✔ Executive-Level Due Diligence Report

Our reports are clear, concise, and decision-focused, supporting stakeholders during mergers, acquisitions, in-licensing, out-licensing, or vendor selection.

Who Should Use This Service?

Pharmaceutical & Biotech Companies
Medical Device & Combination Product Manufacturers
CROs & PV Service Providers
Investors, Acquirers & Business Development Teams
Marketing Authorization Holders (MAHs)

Why Choose CMPV Consultancy LLP?

✔ Experienced Pharmacovigilance Auditors
✔ Deep Global Regulatory Expertise
✔ Risk-Based & Business-Focused Audits
✔ Independent & Confidential Assessments
✔ Practical, Implementable Recommendations

We don’t just identify gaps—we help you understand the impact and path to compliance.

Value You Gain

Reduced regulatory and commercial risk
Clear understanding of PV liabilities
Improved negotiation and decision-making
Faster post-deal integration readiness
Enhanced patient safety oversight

Partner with Confidence

Whether you are evaluating a potential partner, acquiring a product, or outsourcing PV activities, CMPV Consultancy LLP ensures your pharmacovigilance framework is robust, compliant, and future-ready.

📩 Contact CMPV Consultancy LLP today to discuss your Pharmacovigilance Due Diligence Audit requirements.