Compliance Services
Corporate Compliance
Leading and forward-thinking companies are focused on opportunities to proactively mitigate risk of legal and regulatory noncompliance. However, companies face numerous challenges when managing compliance risks: enforcement actions, regulatory guidance, global operations, and business structure.
Although the basic requirements of “effective” compliance are well known, the “how-to” and “how-much” are dependent on each company’s risk profile. Therefore, companies must address risk from multiple lenses: strategy, management, and monitoring.
Our experienced team of experts provide industry expertise and detailed knowledge of regulator expectations to develop and implement proactive risk mitigation strategies; detect violations of company policies, procedures, and controls; and identify the root cause of issues and provide actionable recommendations to strengthen controls and mitigate future breakdowns.
Service Examples
- Evaluating, developing, and enhancing anti-Fraud, anti-Bribery & anti-corruption, and third-party risk corporate compliance programs
- Drafting financial and third party policies
- Assisting with periodic and targeted compliance-focused risk assessments
- Performing third party risk assessments
- Assessing design and implementation of internal and operating controls
- Conducting internal and external audits
- Preparing for government reviews and audits (e.g., Paycheck Protection Program)
- Assessing third party compliance with policy, procedures, and other ethical terms and conditions
- Performing annual check-ups and compliance reviews
- Working with internal and external counsel to coordinate issue reporting to the IROs, the OIG, and State Attorney Generals
- In conjunction with external counsel, performing pre-IRO testing of sales representative interactions involving speaker programs and HCP meals
- Working with external counsel to evaluate adherence to FDA promotional guidelines and implementing modified protocols by reviewing the associated operations, systems, and regulatory filings
- In conjunction with external counsel, evaluating patient assistance programs, policies, and associated transactions
Contract Compliance
Contractual obligations have become commonplace in businesses: loans, grants, and any contracts binding parties to a set of commitments. The legal binding requires the parties to take certain actions and understand that noncompliance may trigger unwanted consequences that can interrupt the flow of business.
However, identifying noncompliance may prove to be difficult and confronting, depending on the imposed terms as well as available resources. Our team of contract compliance experts can provide the guidance and the skills required to navigate complex contracts, assess terms and conditions, and ascertain whether parties are complying with their respective commitments.
Service Examples
- Testing compliance with key contract terms
- Identifying and calculating revenue leakage
- Performing annual check-ups/reviews
- Communicating and working with the regulators