Life Sciences Disputes Compliance & Investigations
In the complex regulatory environment of today’s Pharmaceutical, Biotech, Medical Device and Diagnostics industries, companies and their counsel face an increasing number of dispute, compliance and investigation issues that have the potential for significant financial, economic and reputational impact. Companies need to secure oversight that represents an intimate knowledge of the laws and regulations of the industry and how each of the functional areas within a Pharmaceutical, Biotech, Medical Device and Diagnostic company operate.
Our professionals combine litigation and investigative experience with industry knowledge to assist clients with compliance and risk mitigation services; dispute resolution and litigation support; fraud and other special investigations; antitrust matters; class action services; breach of contract analysis; and data analysis and information systems consulting. Our collective industry experience provides our professionals with a cross-industry understanding of potential solutions that our clients regularly leverage.
Click here to view our insights and perspectives on the Sunshine Act and the Final Rule for Implementation.
Click here to view our Life Sciences Article series.
Our services include:
- Damages analysis
- Contract dispute/analysis
- Intellectual property
- Government pricing and rebates, and contract compliance
- Clinical data analysis
- Product liability
- Expert witness testimony
- Comprehensive compliance program assessment and support
- Government enforcement support: IROs, CIAs, DPAs and monitorships
- Board level compliance effectiveness certifications
- Discrete issue compliance assessment
- Contract/vendor compliance
- Technology solutions development
- Fraud and other special investigations
- Government shadow investigations
- False claims/qui tam investigations
- Fraudulent billing investigations
- Off-label pharmaceutical practices
- Sales and marketing practices
Managing Complex Risks in Life Sciences Organizations
Life Sciences Compliance Services
Sunshine Act Auditing and Monitoring Readiness
An international pharmaceutical company needed to improve efficiencies and strengthen compliance with business processes centered on transfers of value to physicians as part of its overall transparency initiative. Through document and data flow reviews, interviews, and working groups, Navigant assessed the company’s current “HCP spend” data generation, collection and reporting policies, processes and capabilities. Navigant assisted the company in identifying its current gaps in being able to effectively respond to potential future audits, inquiries or investigations. Our team helped develop long-term, prioritized technology requirements, prepare and streamline near-term aggregate spend collection processes, and adapt the client’s overall compliance program to address the gaps.
Department Of Justice Launches Anti-Kickback Investigation
A global medical device company received a subpoena related to their contractual arrangements with healthcare professionals. Outside counsel turned to Navigant to investigate the company’s arrangements and determine risk, support settlement activity and recommend actions to address risks. The Navigant team established a statistically relevant sample, analyzed extensive data sets and quantified the potential risk and related exposure. Working with outside counsel, our recommendations provided a road map to ensuring healthcare professional arrangements were established with the appropriate controls to manage risks associated with the Anti-Kickback Statute.