Pharmaceutical, biotech, clinical laboratory, and medical device organizations must prepare for and manage a new surge of regulatory review and enforcement actions. Failing to comply with changing regulation can have serious consequences, including fines, criminal prosecution and debarments.
At KPMG, we can help you assess business practices and monitor programs to avoid problems proactively and, when necessary, we investigate and testify to help you manage the potential consequences of alleged compliance failures. We can help you in all phases of the regulatory compliance life cycle, from the development of a robust compliance program through benchmarking, investigation, remediation, and recovery in instances of misconduct or noncompliance.
We assist your organization in fundamentally reassessing and retooling your compliance governance, compliance culture, and business and risk operations. This includes aligning your compliance programs to the specific requirements of your industry, anticipating regulatory changes, and helping achieve industry leading results.
KPMG has extensive experience with the legal/regulatory environment and a distinct operating model that drives government, commercial, and medical affairs’ risk mitigation controls and compliance needs. We understand the False Claims Act, Anti-Kickback Statute, Foreign Corrupt Practices Act, Corporate Integrity Agreements, and the relevant regulated areas, such as government pricing, spend transparency reporting, PhRMA/Advamed codes, third-party risk management, fair market value, data protection and privacy, PAMA, and good clinical/ manufacturing practices.
Learn more about KPMG's healthcare and life sciences practice.