Services
Life Sciences Compliance
Empowering Life Sciences with Strategic Compliance, Global Regulatory Expertise, and Business Insight
The Ankura Life Sciences practice offers unparalleled expertise, shaped by 25 years of navigating the industry's toughest challenges. Our team, composed of seasoned compliance officers, general counsel, and litigation experts, collaborates with pharmaceutical, biotech, medical device, technology, and diagnostics companies globally. We specialize in building, scaling, and evaluating robust compliance programs, enhancing risk management strategies, and addressing government scrutiny. Our pragmatic approach ensures compliance programs are tailored to meet evolving regulatory standards set by authorities like the Department of Justice (DOJ), U.S. Food and Drug Administration (FDA), and Securities and Exchange Commission (SEC), along with industry codes such as PhRMA and AdvaMed. With a focus on actionable results, Ankura empowers clients to thrive in a complex global market.
Ankura's Life Sciences practice offers comprehensive services designed to address industry challenges with expertise and advanced data analytics. Our experienced team collaborates with clients to build, scale, and evaluate compliance programs, enhance risk management strategies, and respond to government scrutiny, ensuring sustainable and actionable results.
Offerings
- Compliance and Advisory Services
- Compliance Audits & Advisory
- Compliance Program Effectiveness Reviews
- Strategic Advisory for Compliance Executives, General Counsel, and Boards of Directors
- Compliance Auditing and Monitoring
- Data Privacy and Security
- Transparency Reporting (Federal, State, & Global)
- Investigations and Monitoring
- Government and Internal Investigations Support
- Independent Monitorship
- Pre-IRO Consulting and Enforcement Decree Implementation Services
- Consent Decree, Corporate Integrity Agreement, and Deferred Prosecution Agreement Review
- Records Review and Analysis
- Litigation and Expert Services
- Litigation Support and Expert Testimony
- Expert Witness Services
- Board Advisor Services
- Strategic and Risk Management
- Enterprise Risk Assessment
- Third-Party Due Diligence and Risk Management
- Turnaround & Restructuring
- Mergers, Acquisitions, and Valuation
- Healthcare Data Analytics
- Additional Offerings
- Patient Support Programs
- Fair Market Value Assessments
- Artificial Intelligence and Governance
Our Latest Thinking
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Compliance Program Overhaul
A leading pharmaceutical company faced challenges with outdated compliance frameworks that risked non-compliance with evolving regulations. Ankura was engaged to assess and revamp their compliance program. Our team conducted a thorough audit, identified gaps, and implemented a scalable compliance solution tailored to the company's operational needs. As a result, the company achieved enhanced regulatory compliance and reduced risks of non-compliance penalties.
The Ankura Difference
At Ankura, we differentiate ourselves by engaging at critical inflection points such as mergers, acquisitions, management transitions, government investigations, and high-stakes litigation. Our dedicated focus allows us to thoroughly understand complex challenges and provide tailored, effective solutions. Combining deep industry expertise with advanced technical skills, we deliver comprehensive strategies that transform organizations and ensure successful compliance program enhancements.
Key Contacts
- Katherine C. Norris
Senior Managing Director
Washington, DC
- Dorothy DeAngelis
Senior Managing Director
Phoenix, AZ
- Bernard J. Ford
Senior Managing Director
Chicago, IL
- Stephanie M. Lewko
Managing Director
Washington, DC
- Jeffrey Low
Managing Director
Phoenix, AZ
- Criss DeKreek
Managing Director
Atlanta, GA
