Navigant’s dedicated Life Sciences industry team brings a global perspective and deep subject-matter expertise to address a range of disputes-related issues.  Our professionals serve our clients and their outside counsel in a wide range of capacities, ranging from expert witness, to subject matter expert, independent monitor, compliance/quality auditor, Enterprise Risk Management facilitator, Board advisor, and independent investigator. We offer a full suite of risk, regulatory and compliance solutions and bring innovative approaches that address the most complex challenges facing pharmaceutical, biotech, medical device and diagnostic companies. Our professionals bring a unique combination of direct industry experience, enforcement experience and technical insights that deliver meaningful value to the co-development of a dispute, compliance or investigation strategy and execution.

Solutions

 

  • Expert Witness, Expert Advisory and Quantum Support across a broad range of Life Sciences related matters
  • Mergers and Acquisitions due diligence, transaction support and post deal integration support
  • Class Action Support
  • Product Liability
  • Investigation support (False Claims Act, off label, kickbacks, bribery and corruption, pricing, 483, warning letters, product recalls)
  • Disputes and Compliance
    • Contract disputes involving regulated products and supply chain
    • Third Party risk management and audit
    • Off-label sales and marketing
    • Good manufacturing practices and product development
    • Foreign Corrupt Practices Act, False Claims Act, Stark Law, Anti-Kickback Statute, Sunshine Act
    • Privacy and GDPR
  • Regulatory
    • Regulatory pathway analysis/strategy
    • Pre-clinical strategy
    • CM&C strategy and development
    • Quality system (QS) generation and gap analysis
    • Process and resource mapping
    • Design controls and product realization
  • Market Access
    • Global and US Health Economics and Outcomes Research and Evidence based Medicine
    • Global and US Pricing and Access strategy
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