Compliance & Ethics
Our service offerings include:
- Compliance & Ethics framework effectiveness review and benchmarking
- Compliance & Ethics risk assessment
- Compliance & Ethics strategy development
- Compliance & Ethics framework design, build and implementation, including:
- Governance, structure and operating model
- Roles and responsibilities
- Policies and SOPs
- Training and communications
- Whistleblower hotline
- Compliance & Ethics risk indicators / KPIs and reporting
- Monitoring and investigations
- Incident response planning and testing
- Internal Control design, build and implementation (including: third party due diligence requirements, high risk activities approvals, DPIAs, BCRs / SCCs etc.)
- Transparency reporting
- Third party Compliance & Ethics risk assessment and framework development
- M&A Compliance & Ethics due diligence and post-merger integration support
- Company-wide Compliance & Ethics satisfaction, knowledge and culture surveys
- Remediation plan design and implementation
- Compliance & Ethics software selection and configuration
- Leadership mentoring
- Staffing (part-time, full-time and secondments)
- Fractional / Outsourced CCO (for small / medium sized companies only)
Our areas of expertise includes:
- Healthcare Interactions
- Anti-bribery and corruption (including FCPA, Anti-Kickback Statute, False Claims Act, and UK Bribery Act compliance)
- Compliance with national Pharmaceutical Industry Associations’ Codes of Practice (e.g. EFPIA, PhRMA, ABPI etc.)
- Promotion and Marketing of medicines (e.g. FDA, FTC, EMA, MHRA etc.)
- Data protection (e.g. GDPR, CCPA, HIPPA, COPPA etc.)
- Anti-Trust / Fair Competition
- Intellectual Property / Patent Infringement
- Sanctions
- AML / CTF
- Other legislation (e.g. Modern Day Slavery Act; German Supply Chain Act etc.)