For investors
How does a life sciences portfolio company become sale-ready in regulatory terms before the buyer starts its review?
We prepare the portfolio companies of private equity firms, financial investors, family offices and strategic buyers for the buyer side's due diligence: buyer-ready technical documentation, a mock audit ahead of the actual buyer audit, and evidenced data integrity. What the buyer examines is precisely what went systematically unobserved on the seller side across the holding period, and every finding the buyer surfaces first moves into the purchase-price negotiation instead of into a remediation that would have been possible beforehand.
Overview
The buyer reviews what the seller never reviewed
Last updated: August 3, 2026
Across the holding period a portfolio company is measured on revenue, margin and operating metrics. Its regulatory substance stays unobserved until a prospective buyer examines it from the outside for the first time, and what counts then is not the state of things but the ability to evidence that state.
- A valid certification says nothing about whether the technical documentation withstands scrutiny. The buyer does not read the certificate, but the file behind it.
- Data integrity is the finding that resists late remediation most stubbornly: missing audit trails and systems that were never validated cannot be repaired retroactively.
- Open CAPA items and deviation trends are visible in the data room, their assessment is not. Without the seller's own reading of them, the buyer supplies the interpretation, and it rarely turns out favorable.
- Across several sites, or after earlier acquisitions, documentation has usually grown unevenly. The buyer sees the fault lines faster than the company's own team.
How we support you
Exit & vendor readiness
Related projects
Measured in client mandates
Where projects commonly fail
Exit preparation is started in parallel with the sale process. Whoever begins with the teaser has no room left for documentation gaps and validation backlogs; those findings take months, not weeks, and they are exactly what the buyer side reviews first.
The vendor due diligence is written as a sales document instead of an audit report. A report without findings reads as implausible to an experienced deal team and devalues the points that genuinely are in order.
Data integrity is treated as an IT topic and delegated to IT. Annex 11 and 21 CFR Part 11 call for evidence covering processes, access rights and audit trails that is substantiated together with quality and production, not by IT alone.
Regulations & standards considered
- Regulation (EU) 2017/745 (MDR), Annex II/III (Technical Documentation)
- Regulation (EU) 2017/746 (IVDR), Annex II/III
- ISO 13485:2016 (QM system for medical devices)
- EU GMP Guide Annex 11 (Computerised Systems)
- 21 CFR Part 11 (Electronic Records; Electronic Signatures)
- ISO 14971 (Risk management for medical devices)
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): Annex II and III, Technical Documentation
- Regulation (EU) 2017/746 (IVDR): Annex II and III
- ISO 13485:2016: Quality management systems for medical devices
- EU GMP Guide Annex 11: Computerised Systems
- 21 CFR Part 11: Electronic Records and Electronic Signatures
- Entourage case study: datenintegritaet-csv-pharma (39% fewer data deviations, 30% more validation output, FDA audit passed)
- docs/PRIVATE-EQUITY-HUB-KONZEPT.md, sections 4a and 8a (metrics with a named source, writing rules)
Related topics