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.”