Regulatory Compliance, Investigations, and Disputes
The life sciences industry is one of the largest and fastest growing segments of the U.S. economy. It is also one of the most heavily regulated. Never before have the operational and regulatory demands on the industry been as great.
FTI Consulting life sciences clients come to us for practical, immediate, sustainable solutions
A surge in Federal False Claims Act cases has been matched by a growing prevalence of state-level false claims statutes, increasing both the likelihood and costs of additional whistleblower litigation. In addition, a steady expansion of government enforcement resources has been accompanied by new and increasingly complex regulatory requirements.
The risks related to regulatory compliance issues have increased dramatically. Healthcare and life sciences companies need access to high-quality assistance in conducting investigations and addressing compliance-related allegations.
To meet these challenges, the FTI Consulting Regulatory Compliance, Investigations, and Disputes team combines the skills of industry specialists with those of investigative professionals, forensic accountants, compliance experts, computer forensic specialists, and electronic evidence and technology consultants. Our team offers in-depth experience in addressing transactional, legal, and regulatory challenges.
FTI Consulting professionals have sat side by side with legal teams and participated in settlement negotiations with a wide variety of government agencies including the DOJ, CMS, OIG-HHS, the USAO, and numerous state AG offices.
Our broad and deep resources enable us to confront issues intelligently and efficiently, whether we are conducting investigations, responding to information requests and subpoenas, supporting litigation-related activities, assessing the effectiveness of compliance programs, or supporting decision-making by management and boards. We are able to help both in responding to immediate threats and in developing appropriate strategies for preventing, detecting and resolving compliance problems.