Case studyIVD

M&A Due Diligence and Post-Merger Initiative Roadmap for a Diagnostics Manufacturer

Diagnostics manufacturer following a corporate acquisition

Following an acquisition, a diagnostics manufacturer faced limited process maturity, a lack of digital and regulatory strategy, and no procurement or S&OP organization, creating quality, compliance and scaling risks across eight operational workstreams.

The challenge

The situation

Following an acquisition, a diagnostics manufacturer faced limited process maturity, the absence of a digital or regulatory strategy, and a missing procurement and sales-and-operations-planning organization. These gaps carried quality, compliance and scaling risks across eight operational workstreams and required a due diligence with a strategic roadmap to safeguard value creation after the merger.

Our approach

What we delivered

Structured due diligence across eight core operational workstreams to identify gaps in manufacturing, QC, design control and IT

Strategic prioritization of identified risks by strategic, tactical and operational relevance

Development of a concrete initiative roadmap to steer value creation after the acquisition

The outcome

Results & impact

8 workstreams analyzed

Due diligence conducted across manufacturing, QC, design control and IT.

0 unresolved critical risks

All critical quality, compliance and scaling risks identified and addressed.

9 prioritized initiatives

Roadmap developed with nine prioritized initiatives to steer value creation after the acquisition.

In summary

The manufacturer received a complete due-diligence analysis across eight operational workstreams and a concrete roadmap with nine prioritized initiatives, with no open critical risks.

Related expertise

M&A & PMI →

Regulatory due diligence, integration strategy and merging two quality cultures

Regulatory Due Diligence →

In-depth analysis of the quality management system to ISO 13485:2016 and assessment of MDR/IVDR transition status

Design Controls →

Design reviews at defined milestones and an end-to-end traceability matrix

Compliant Procurement Excellence →

Building auditable procurement processes with SOPs and procurement KPIs

Similar projects

Global Market Access After the IVDR Transition: 100 Percent On-Time TGA Submissions

Following the transition to the IVDR, a diagnostics manufacturer had to meet pressing compliance deadlines set by the Australian Therapeutic Goods Administration, with limited internal capacity and diverging requirements across multiple international markets.

IVD

IVDR Certification for Class C and Class D IVDs: Complete Annex II/III Documentation

An IVD manufacturer faced critical IVDR deadlines for its Class D products, with limited internal capacity for the extensive regulatory, clinical and analytical requirements and insufficient evidence for the conformity assessment.

IVD

Post-Merger Integration of a Diagnostics Manufacturer: 25 Percent COGS Reduction

Following a strategic acquisition, a diagnostics manufacturer had to integrate operations, stabilize manufacturing and quality control, and close digital and regulatory gaps to protect cost of goods sold and accelerate time to market.

Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.

Sources

Entourage project experience (anonymized)

Your project

A comparable project?

Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.

Prefer direct? +49 89 4161170-0
info@theentourage.de

Reply usually within one working day
4 offices: DE · CH · IT · US
100% life sciences