Expertise
Regulatory Science
“Translating science into strategy is key to achieving short- and long-term business goals.”
Kelly L. George
Principal
Demonstrate Product Value
Delivering end-to-end scientific and commercial support and solutions, we work closely with you to navigate the regulatory strategy and FDA policy environment to secure patient access with effective value demonstrations. We solve today’s regulatory and commercial challenges and help you anticipate future demands in drug development and managing a product’s lifecycle.
Master the
Evolving Market
We anticipate and identify today's challenges, opportunities, and top trends to watch.
Customized Solutions
Whether you are from a life sciences company, plan, or provider, we have you covered.
Biologics, Biosimilars & Interchangeables
Clinical Guidelines & Publication Planning
Due Diligence & Commercial Viability Analysis
Evidence Communication, Advertising & Promotion
Expanded Access Pathway, Compassionate Use & Right-to-Try
FDA Approval Pathway Strategy
FDA Engagement Approaches
FDAMA 114 Assessment & Insight
Label Differentiation & Value Proposition
Legal, Regulatory & Policy Analysis Impact & Considerations
Life-Cycle Pipeline Management
Patient Engagement & Drug Development
Real-World Data/Evidence for Regulatory Decision Making
Regulatory Risk Mitigation