Operational Due Diligence for an M&A Integration
Life-sciences manufacturing company in the course of an acquisition
In the course of a merger, inconsistent compliance and limited standardization shaped the operations of the newly combined organization.
The challenge
The situation
In the course of a merger, the company faced inconsistent compliance and limited standardization in its operations. The absence of standardized processes and quality management systems posed a considerable risk to the integration and optimization of the newly combined organization.
Our approach
What we delivered
Review of regulatory affairs compliance, because inconsistent compliance is the first integration risk in any merger.
Evaluation of the supply chain at the points where two organizations with different standards come together.
Assessment of the digital systems, so that it is established before the merger which quality management systems are compatible at all.
The outcome
Results & impact
Three assessment areas
Due diligence across regulatory affairs, supply chain and digital systems.
Integration risks identified
Transparency created over the organization's compliance and integration gaps.
In summary
The operational due diligence makes the transaction's compliance and integration risks transparent and creates a sound basis for combining the organization.
Related expertise
M&A & PMI →
QMS gap analysis, integration strategy and post-merger compliance with authorization transfers
Regulatory Due Diligence →
A red-flag report on marketing-authorization status and authority communications, with an in-depth QMS analysis
Manufacturing & Supply Chain Management →
Resilience against supply shortages and GDP-compliant logistics management
Digital Governance →
System inventory with GAMP 5 criticality assessment and defined system ownership across IT, QA and business
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Sources
- Entourage project experience (anonymized)
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