Private Equity

Technical scrutiny across the full deal cycle.

Private equity firms, financial investors and family offices with holdings in pharma, biotech, MedTech and IVD: from regulatory due diligence before signing through value creation during the hold period to sale readiness ahead of the exit.

Technical & regulatory due diligence

Red-flag assessment before signing: quality system, approval status, authority history and GMP compliance, condensed into a basis for decision.

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Value creation

Operational value creation during the hold period: manufacturing excellence, quality system remediation, supply chain and digitalisation.

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Post-merger integration

Bringing operations together after closing: quality systems, regulatory portfolio, suppliers and IT landscape.

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Exit & vendor readiness

Regulatory pre-check before the sale: buyer-ready technical documentation, mock audit and demonstrated data integrity.

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Our expertise

The same scrutiny, across all five areas of expertise.

A deal rarely touches just one discipline. We assess a target or portfolio company with the same specialist teams that run approvals, pass audits and relocate production day to day. What changes is only the question put first: the investor’s.

Product Development & Regulatory Strategy

From classification and regulatory strategy through to development and study planning.

Typical DD finding: MDR classification is not re-checked at signing. A product that has moved into a higher risk class since the last submission only changes effort and timeline after closing.

Market Access, RWE & Reimbursement

Market access, health economics, real-world evidence and pricing and reimbursement strategy.

Typical DD finding: Value-dossier status is listed as "in progress" in the data room without an AMNOG or HTA date behind it. Without a date, reimbursement is not a timeline but a hope.

Regulatory Affairs

Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.

Typical DD finding: MDR/IVDR transition status is taken from an internal list rather than from correspondence with the notified body. A certificate that formally "runs" can already have stalled in processing.

Quality Management & Compliance

QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.

Typical DD finding: CAPA backlogs get cleared before due diligence, but the cycle time to closure stays visible in the QMS. It shows whether that was a system change or a one-off push before the data room.

Supply Chain & Technical Operations

Supply chain, manufacturing, shortage management and technical operations optimization.

Typical DD finding: A supplier change or capacity expansion shows as complete in the data room even though process validation at the new site is still open. A manufacturing risk no balance-sheet metric shows.

Related projects

Results from real mandates.

Two mandates from our own history, each with its case and a link to the published case study: no range without evidence.

In a post-merger programme at a diagnostics manufacturer, cost of goods sold fell by 25%, time-to-market shortened by 30%, and forecast accuracy improved by 20%: across nine integrated workstreams spanning process validation and CAPA governance, TrackWise and ERP, through to procurement governance and S&OP.

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

At a diagnostics manufacturer, a due diligence across eight operational workstreams (manufacturing, quality control, design control and IT) captured every critical risk after the acquisition and fed into a prioritised roadmap of nine initiatives, with zero unresolved critical findings.

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

Private Equity

How we deliver.

For the phases after closing we do not act as assessors but as implementers: 100-day plan, transformation PMO, KPI tracking and workstream steering, with interim staffing where needed. Governance sits with a steering committee of investor and management, the PMO coordinates and reports, the operational workstreams execute.

Experience on both sides.

We work for manufacturers and for investors. That is not a contradiction but the reason the assessment holds: whoever has lived through audits, submissions and inspections recognises faster which finding touches the deal and which is merely a footnote. Before any buy-side mandate we check for conflicts of interest with existing client relationships.