Case Studies
Regulatory Due Diligence
Client
Private Equity Firm
Industry
Pharmaceuticals
Business Challenge
Study regulatory, operational, and quality aspects of a target enterprise
Background
A private equity firm pursuing the acquisition of a global medical enterprise engaged Regulatory Compliance Associates® Inc. (RCA) to perform a comprehensive technical due diligence analysis under a highly compressed timeline. The target company operated across North America, Europe, and East Asia, introducing significant complexity and potential risk.
Given the regulated nature of the enterprise, the risks spanned multiple dimensions—including technical, operational, legal, and compliance—with the potential to impact both valuation and deal structure. In addition to identifying critical risks, the private equity firm requested that RCA evaluate the company’s scalability and flag any infrastructure or regulatory barriers that could influence the transaction or provide leverage during negotiations.
Approach
RCA immediately mobilized a cross-functional team of regulatory, technical, and quality subject matter experts. Within 24 hours, appropriate resources were assigned to assess the target company’s regulatory compliance, operational readiness, and quality systems.
Using data room materials and client input, RCA rapidly identified key risk areas and developed a prioritized assessment plan. A detailed due diligence checklist was created to guide the evaluation process during on-site visits.
Over an intensive eight-day period, RCA conducted nineteen facility assessments and a corporate headquarters review. Throughout the engagement, the client received daily updates that were incorporated into active deal negotiations.
Result
RCA delivered a comprehensive due diligence report covering regulatory, technical, and quality-related findings, along with quantified assessments of health and safety liabilities, infrastructure gaps, and remediation costs. Expansion capabilities and potential structural limitations were also mapped, allowing the client to make fully informed decisions.
The findings provided the private equity firm with powerful insights that supported a successful negotiation and enabled them to adjust the purchase price to account for uncovered risks. RCA’s real-time guidance and expert recommendations ensured the client had a strategic advantage throughout the transaction process.
