Life Sciences
Forward-thinking life sciences companies are shaping the technology that will improve the lives of patients, customers and communities. FTI Consulting’s world-class capabilities across pharmaceuticals, biotechnology, medical device and diagnostics, and the healthcare ecosystem enable us to assist clients in solving their most complex challenges and achieving their strategic and operational objectives.
Our life sciences services and solutions build on our core value of consistently serving our clients and patients with distinction and excellence along the complete value continuum.
Insights
How We Help
Clinical Lifecycle Management
Clinical Lifecycle Management (CLM) is critical for life sciences companies in the early stages, commercialization,...
Clinical Lifecycle Management (CLM) is critical for life sciences companies in the early stages, commercialization, and throughout the lifecycle for sustainability. We deliver comprehensive, global clinical strategies and portfolio optimization to help our clients build and enhance their product journey across non-clinical development, clinical research and operations, market access and growth.
Our CLM services and solutions include but are not limited to:
Non-clinical development (non-human involvement):
- Non-clinical development strategy
- Animal and analytical study design, protocol and report generation
- Assay qualification and validation
Clinical research and operations:
- Protocol development and overall evidence strategy
- End-to-end study operations
Commercialization:
- Clinical/Regulatory combined strategies
- Data analytics to support regulatory submissions
Operational excellence:
- CRO and advisory board management
- Portfolio valuation assessments and strategic recommendations
Market sustainability:
- Health economic outcomes research (HEOR)
- Post market study design
Regulatory
Regular assessment of your regulatory capabilities, streamlining your regulatory processes and strengthening...
Regular assessment of your regulatory capabilities, streamlining your regulatory processes and strengthening integration across regulatory affairs, business and the broader healthcare ecosystem are core to continued development. In performing these functions, we help our clients accelerate time to market, improve quality and probability of regulatory success, increase operational efficiency, and optimize regulatory and trade compliance.
Our regulatory services and solutions include:
- Regulatory strategy
- Operating model enhancement
- Regulatory information management
- Capability maturity assessments
- Intelligent automation (use of RPA, ML, NPA and other AI technologies)
- Regulatory intelligence
- Business integration
- Submission process optimization
Quality
Quality in the life sciences industry has historically focused on compliance.
Quality in the life sciences industry has historically focused on compliance. FTI Consulting is helping companies move beyond compliance to achieve a culture of excellence and enjoy the benefits of ongoing improvements. We assist pre-revenue and emerging companies as well as large enterprise organizations in the pharmaceuticals, biotechnology, medical devices and diagnostics sectors. Our goal is to help you develop an effective quality management system (QMS) and company culture that is poised for continuous improvement and maturity and able to deliver leading performance and sustained regulatory compliance.
Our services and solutions include:
- Product quality strategy
- Quality management system optimization
- Quality process excellence
- Culture of quality/change management
- Regulatory compliance remediation
- Quality and risk analytics
- Quality risk management
- Data integrity across the enterprise (and extending to suppliers and partners)
- IT quality and compliance management processes
- Computerized system validation
- Cybersecurity and privacy
Supply Chain and Manufacturing
The end-to-end Supply Chain and Manufacturing group brings traditional and innovative supply chain management...
The end-to-end Supply Chain and Manufacturing group brings traditional and innovative supply chain management solutions to life sciences organizations at all stages. This encompasses emerging pharmaceutical organizations, where clinical and commercial operations have yet to be established, to mature portfolios looking to sustain growth or tap into new distribution channels, and conventional small-molecule or medical devices to innovative fields like CAR-T, allogeneic gene therapy or digital surgery.
FTI Consulting can help you find a desired balance between service, cost and capital while building end-to-end supply chain and manufacturing systems with the necessary processes and technology to achieve:
- Revenue generation
- Margin improvement
- Asset efficiencies
- Risk reduction and brand protection
To achieve maximum enterprise value, engage FTI Consulting’s Life Sciences end-to-end Supply Chain and Manufacturing Operations team on varying initiatives, including but not limited to:
- End-to-end network strategy and design
- Operational and product segmentation
- Sales and operations planning/supply chain planning
- Operational cost reduction and spend analysis
- Supply chain process development and system selection
- Multitier supplier risk and brand protection programs
- Brand protection
- Control tower visibility, communications and “follow the sun” approach
FTI Consulting Cell and Gene Therapy
Cell and gene therapy is revolutionizing healthcare. But its efficacy relies on good old-fashioned supply chain management. Can your chain of identity stand up to today’s risks?
