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

• 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