Regulatory & Compliance
Regulatory due diligence.
Identify hidden compliance risks before they become a problem. We conduct structured regulatory due diligence for buyers, private equity investors, and merger partners in the life sciences sector—including a systematic assessment of red flags related to QMS, regulatory status, regulatory history, and GMP compliance.
What regulatory risks are often overlooked in life sciences M&A?
Regulatory risks are often not immediately apparent in corporate acquisitions—until they jeopardize the deal or become extremely costly after closing.
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History of the Agency.
Open FDA warning letters or EMA statements regarding a target often do not come to light until very late in the standard due diligence process.
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QMS backlogs.
A massive CAPA backlog or unresolved major findings from regulatory inspections can seriously hinder the integration process.
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Approval status.
Some products may still be approved under outdated regulations (MDD)—the transition to the MDR is not yet complete, and market access is at risk.
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Compliance culture.
Although the acquired company formally has a quality management system in place, there is no active, well-established quality culture.
Did you receive a specialized regulatory due diligence report during your last acquisition—or just a superficial legal and financial assessment?
Regulatory due diligence for M&A and private equity.
We provide comprehensive regulatory risk assessments to serve as a solid basis for decision-making regarding your transaction.
Regulatory Red Flag Report
Systematic assessment of the regulatory status of all products: CE certificates, FDA approvals, and national regulatory status. We review pending communications with regulatory authorities, ongoing inspection findings, and warning letters. The structured red-flag report includes a clear criticality assessment.
QMS Assessment & Gap Analysis
In-depth analysis of the target’s Quality Management System (QMS): CAPA backlog, deviation trends, complaint rates, and audit results from the past three years. We evaluate the ISO 13485 certification status, the GMP inspection history, and known systemic deficiencies.
Admissions Portfolio Assessment
Comprehensive and systematic assessment of the product portfolio for regulatory risks. We review the current MDR/IVDR transition status, expiring certificates, gaps in clinical evidence, missing PMCF data, and the EUDAMED database status to ensure reliable due diligence.
Risk assessment relevant to the purchase price
Quantifying identified regulatory risks: We calculate the costs associated with necessary QMS remediation, pending MDR transitions, or post-approval compliance work. We recommend strategic adjustments to the purchase price, integration budget, or specific escrow clauses.
Frequently Asked Questions About Regulatory Due Diligence.
When should regulatory due diligence be conducted?
Ideally during Phase 2 due diligence—after the LOI and before the SPA. Identifying red flags early on allows for purchase price adjustments, escrow agreements, or an informed withdrawal. Post-closing repairs usually cost several times as much.
What is a regulatory red flag report?
A red flag report is a concise, risk-based summary of due diligence findings—intended for M&A teams and investors, not for regulators. It prioritizes findings by criticality and assesses financial implications to provide a clear basis for decision-making.
What documents are needed for due diligence?
Important documents include: inspection reports and correspondence with regulatory authorities from the past 5 years, current CAPA status, QMS certificates, a list of all products with their approval status, open deviations and OOS trends, the vigilance status, and CSV validations.
Can regulatory due diligence be conducted remotely?
To some extent. An initial document review and remote interviews with quality and regulatory leads are possible and often sufficient for an initial red-flag assessment. However, an on-site inspection of the production facilities is strongly recommended for a more in-depth evaluation.
Related topics.
Make sure your M&A decisions are sound.
Let’s discuss the specific compliance risks associated with your potential target in a confidential initial consultation.