CMC
- Manufacturing strategy and operations
- Process development and optimization
- CDMO selection and outsourcing support
- Project integration
- Quality
- Development of comparability assessment strategies
- CMC regulatory gap assessments
Regulatory and Clinical Pharmacology
- Development of global and country-specific regulatory strategy
- Support for interactions with health authorities
- Feasibility analysis of the proposed bioequivalence strategy
- Gap analysis including critical review of documents and elaboration of remediation plan
- Full clinical pharmacology support
- Preparation and submission of regulatory dossier to health authorities
Clinical and Biometrics
- Clinical development consulting
- Clinical trial design and execution
- Protocol writing/design
- Full-service trial management
- Data monitoring committees
- Project and stakeholder management
- Data safety monitoring
- Adverse event management
Market Access
- Global market access, pricing and reimbursement strategy
- Optimized pricing strategy and models
- Mock negotiations and payer consultations
- HEOR strategy
- Value communications
- Value-based access programs
- Market research (HCP and payer experts)
- Market access pathways and purchase procedures
- US pricing and contracting strategies
Commercial
- Market opportunity and landscape assessments
- Commercial and strategic due diligence
- Integrated launch planning
- Commercial strategy and go-to-market model development
- Portfolio review
- Corporate strategy planning
- US go to launch tactics
- US buy and bill customer approaches
- US oncology ecosystem strategies
- Segment strategies including hospitals, GPOs, HCPs
Transaction Advisory
- Asset in-licensing
- Asset out-licensing
- Carve-outs
- Divestments
- Buy-side / Target Search and Screening
