Guidehouse’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. Our solutions include:

  • 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
  • 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 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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