DRUG DEVELOPMENT

  • CMC clinical and commercial development
  • Clinical development strategy and protocol design
  • API route selection and process R&D
  • Drug product process and formulation R&D
  • Analytical sciences / process-based analytics
  • QbD strategies / implementation and PAT innovation

DISCOVERY RESEARCH

  • Target Discovery Acceleration
  • Human Confidence in Target Rationale
  • Structure-Based Drug Design
  • Fragment-Based Lead Identification
  • Lead Optimization Process Automation
  • Virtual Discovery Environment Utilization

MANUFACTURING SCIENCES

  • Modular platform technology innovation
  • Continuous manufacturing systems and processes
  • Technology transfer strategy and implementation
  • Pharma 4.0 concept realization strategies
  • Process control and PAT design and implementation
  • Commercial product development & operational excellence



 

Digital and Data Innovation

  • Digital and data strategy creation and implementation
  • Maximizing value from available data
  • Increasing productivity with AI / Machine Learning
  • Harnessing ‘critical workflow’ block-chain technologies
  • Ensuring knowledge custody and accessibility
  • Organizational transformation through digital innovation

CMC REGULATORY SCIENCES

  • All aspects of IND and NDA submissions
  • Post-approval life cycle management
  • Pre-approval inspection readiness
  • Due diligence: Assessment, analysis, recommendations
  • API, drug product, dosage form CTD modules 2 & 3
  • Guidance documents: Interpretation & assessment

SUPPLY CHAIN INNOVATION

  • Outsourcing, shared services, and network optimization
  • Risk assessment and mitigation
  • Serialization strategies, technologies and processes
  • Vendor selection, qualification, contracting, and support
  • Leveraging digital technologies
  • Time-to-market acceleration



 

ENTREPRENEURIAL BUSINESS DEVELOPMENT

  • Landscaping, open innovation, and investment processes
  • Due diligence for CMC section of in-licensing candidates
  • Strategic initiatives, collaborations and partnerships
  • Leveraging R&D ecosystems, including incubator firms
  • Internal and multi-party stakeholder alignment
  • Creating impactful business cases