Due Diligence — Know What You're Acquiring
Audit & Inspection
Due Diligence — Know What You're Acquiring
Regulatory and quality due diligence that gives you a clear picture of the compliance risks, liabilities, and remediation costs before you close a transaction or partnership.
Regulatory and quality liabilities are among the most significant — and most frequently underestimated — risks in M&A transactions and licensing deals. A target company with undisclosed warning letters, pending FDA enforcement actions, or quality systems that cannot support the acquirer's product portfolio can transform a promising acquisition into a costly remediation project. Tomorrow's Crop provides regulatory and quality due diligence that gives you an accurate picture of what you are acquiring — before you commit.
What We Do
A detailed breakdown of our capabilities in this practice area.
Regulatory Status Assessment
Assessment of the target's regulatory status — reviewing FDA inspection history, warning letters, import alerts, consent decrees, and pending regulatory actions that could affect the transaction.
Quality System Assessment
Assessment of the target's quality management system — evaluating QMS maturity, compliance with applicable regulations, and the investment required to bring the system to the acquirer's standards.
Product Portfolio Assessment
Regulatory assessment of the target's product portfolio — reviewing product classifications, approval/clearance status, post-market compliance obligations, and regulatory risks associated with each product.
Manufacturing Site Assessment
Assessment of manufacturing sites — evaluating GMP compliance, facility condition, equipment qualification status, and the capital investment required to maintain or improve compliance.
Regulatory Liability Quantification
Quantification of regulatory liabilities — estimating the cost of remediating identified compliance gaps, responding to pending regulatory actions, and bringing the target's quality systems to required standards.
Integration Planning
Regulatory and quality integration planning — defining the sequence of integration activities, identifying integration risks, and developing a roadmap for post-close regulatory and quality integration.
Licensing & Partnership Due Diligence
Due diligence for licensing deals and strategic partnerships — assessing the regulatory status and quality capabilities of potential partners before entering into agreements.
Post-Close Remediation Support
Support for post-close regulatory and quality remediation — implementing the integration plan, addressing identified liabilities, and building the combined organization's quality infrastructure.
How We Work
Scope Definition
We define the scope of the due diligence engagement — identifying the products, facilities, and regulatory jurisdictions to be assessed, and the specific risk areas to prioritize.
Document Review
We review available regulatory and quality documentation — FDA inspection records, quality system documentation, product registrations, and compliance history.
Site Assessment
Where feasible, we conduct on-site assessment of manufacturing facilities and quality systems — providing direct observation of compliance status.
Risk Assessment & Quantification
We assess and quantify identified regulatory and quality risks — estimating remediation costs, timeline impacts, and deal-breaker risks.
Due Diligence Report
We prepare a comprehensive due diligence report that documents findings, quantifies risks, and provides recommendations for deal structuring, representations and warranties, and post-close integration.
Outcomes You Can Expect
Why Tomorrow's Crop
Regulatory and quality due diligence requires both technical expertise and commercial judgment — understanding not just what the compliance gaps are, but what they mean for the transaction. Our due diligence team has assessed targets across pharmaceutical, medical device, food, supplement, and cannabis industries — and has helped acquirers avoid costly post-close surprises.
Deepen Your Knowledge
Insights, ready-to-use documents, and training programs related to this practice area.
Insights
- Understanding FDA Inspection Priorities in 2026
- Building a QMS for a Regulated Startup
- Preparing Your Quality Unit for an FDA Inspection
Document Resources
- Regulatory Due Diligence ChecklistTC-REG-ADV-004
- Quality System Maturity Assessment FrameworkTC-AUDIT-ADV-002
- Risk-Based Audit Program DesignTC-AUDIT-ADV-001
- FDA Inspection Readiness ChecklistTC-AUDIT-FUND-002
Ready to move forward?
Schedule a discovery call and let's define the right engagement for your organization.