Bridging Risk Gaps: Compliance Assurance During a Strategic Merger

Client Profile

Our client is a mid-sized pharmaceutical manufacturing company based in Europe, with over 3,000 employees and global distribution operations. The company initiated an acquisition of a smaller biotech research firm to expand its innovation portfolio and pipeline capabilities. Due to the highly regulated nature of both entities subject to HIPAA, GDPR, and GxP standards a comprehensive compliance review was essential prior to finalizing the merger.

Challenges Faced

Key security concerns included:

  • Lack of unified compliance frameworks across merging entities
  • Disparate data protection protocols impacting GDPR and HIPAA alignment
  • Unclear IT asset inventory and vendor risk management posture
  • Gaps in documentation and audit readiness across business units
Solution

COE Security implemented a tailored M&A Compliance Assurance Engagement, combining:

  • Compliance Control Mapping: Mapped both companies’ policies against HIPAA, GDPR, and GxP frameworks
  • IT & Data Asset Discovery: Identified shadow IT, critical assets, and data flow inconsistencies
  • Gap Analysis & Risk Register: Documented current deficiencies and prioritized remediation
  • Audit Readiness Program: Established controls, documentation standards, and compliance training
Regulatory Compliance Assurance Tasks
  • Mapped 120+ technical and administrative controls across both organizations
  • Performed compliance risk assessments across 10 departments
  • Consolidated data protection impact assessments (DPIAs)
  • Deployed automated policy compliance checks using existing GRC tools
  • Conducted compliance workshops for stakeholders and legal teams
Governance, Strategy, and Readiness Initiatives
  • Created a Unified Governance Charter for compliance ownership post-merger
  • Defined a shared control framework and compliance roadmap
  • Introduced centralized vendor risk management and due diligence processes
  • Automated compliance monitoring with real-time dashboards and alerts
COE Security Service Portfolio
  • M&A Compliance Reviews
  • Regulatory Gap Assessments
  • HIPAA/GDPR/GxP Advisory
  • IT Risk & Control Mapping
  • Data Protection Audits
  • Vendor Risk Management
  • GRC Program Enablement
  • Policy Development & Implementation
  • Security Awareness & Training
  • Compliance Automation & Reporting
Implementation Details
  • Deployed asset discovery tools across hybrid infrastructure
  • Integrated GRC solutions for policy alignment and risk scoring
  • Conducted virtual and on-site training for compliance and IT teams
  • Documented all control mappings and developed audit-ready artifacts
  • Provided weekly compliance scorecards to executive leadership
Results Achieved
  • 95% control alignment across HIPAA, GDPR, and GxP frameworks
  • 60% reduction in compliance gaps within the first 90 days
  • Full audit readiness achieved within 3 months of engagement
  • Improved compliance maturity score from 2.0 to 4.1 (on a 5-point scale)
Client Testimonial

“COE Security brought structure, speed, and expertise to our compliance efforts during a high-stakes merger. Their guidance gave our leadership the clarity and confidence to move forward securely.”