Compliance Program Counseling, Design & Assessment
For two decades we have helped our clients design, operate, and evaluate their global compliance programs as they work to meet expectations of government enforcement agencies, such as the U.S. DOJ, SEC, HHS/OIG, FDA, and other stakeholders. Our work has helped our clients build and implement compliance programs tailored to their unique business models, risks, resources, and preferences. Our work has also led to favorable resolutions with the government enforcement agencies, including the declination of civil and criminal charges and/or the avoidance of monitors.
Our lawyers bring a practical and interdisciplinary approach to their work. One built and led a global compliance program for a $15 billion life-sciences company as its Vice President for Ethics and Compliance. Several spent substantial portions of their careers as federal prosecutors across the country focusing on economic crimes, including civil and criminal health care fraud. All have active practices defending clients in government investigations. We know what it takes to build a practical and effective compliance program, and we understand the government’s expectations.
Our clients’ industries include pharmaceuticals, medical device and technology, financial services, manufacturing, airlines, transportation, automotive, extractives, and technology. Our expertise includes antitrust, corruption (FCPA), health care fraud (Anti-Kickback Act, Stark and False Claims Act), money laundering, government contracting, commercial fraud and embezzlement, financial accounting and internal controls, export control and sanctions, data privacy, and trade secrets.
Frequently, as we defend companies in government investigations, or, at the request of other defense counsel, we are asked to evaluate compliance programs for the purpose of helping to achieve a favorable resolution with the government, and/or avoid a monitor (“pre-monitorship assessments”). We also advise corporate boards on whether their compliance programs meet the requirements of HHS/OIG Corporate Integrity Agreements.
Our services also include designing and building compliance programs, counseling on the day-to-day compliance program operations, performing assessments of business risk, conducting global compliance program assessments, and performing investigations of allegations of misconduct. We have deep familiarity with each element of an “effective compliance program,” including: program governance, structure, staffing and resources; compliance committee structure and operation; codes of conduct; policies and dissemination; compliance education and training; compliance communications; monitoring; third-party, M&A and JV due diligence and integration; investigations programs and protocols; whistleblower responses; auditing and data mining; and compliance incentives in personnel management.
Finally, we help clients with the difficult decision of whether to voluntarily disclose misconduct they have discovered to the government. Should conversations with the government become necessary, we rely on our strong relationships and reputation for integrity with prosecutors nationwide to achieve excellent results.