Services
Strategic. Scientific. Integrated
Comprehensive analytical solutions designed to de-risk development and accelerate your path to patients
Interim Leadership & Strategic Advisory
Experienced scientific leadership and strategic guidance to strengthen analytical organizations, align cross-functional teams, and advance development programs.
- Interim and fractional Analytical Development leadership
- Analytical and CMC strategy across development stages
- Program roadmaps aligned with technical, regulatory, and business milestones
- Oversight of CROs, CDMOs, external laboratories, and technology partners
Analytical & Quality Strategy
Integrated analytical strategies designed to support product understanding, process development, quality control, and regulatory readiness.
- Phase-appropriate analytical control strategies
- Critical quality attribute and product characterization strategies
- Analytical platform and technology strategy
- Alignment of analytical capabilities with product quality and biological function
Assay Development & Product Characterization
Scientific and technical support for developing robust analytical capabilities and establishing a comprehensive understanding of product quality and performance.
- Analytical method and assay development
- Potency and functional characterization
- Product characterization and structure-function assessment
- Analytical technology evaluation and implementation
Comparability & Analytical Lifecycle Management
Risk-based strategies to support process changes, technology transfer, method evolution, and continued analytical performance throughout the product lifecycle.
- Analytical comparability and bridging strategies
- Method qualification, validation, and transfer strategy
- Specification development and analytical performance monitoring
- Critical reagent and method lifecycle management
Stability & Regulatory Support
Integrated analytical and CMC support to strengthen regulatory submissions, stability programs, and inspection readiness from clinical development through commercialization.
- Stability and shelf-life strategy
- Analytical and CMC regulatory support
- IND, BLA, and lifecycle submission support
- Regulatory interaction and inspection readiness