Cell & Gene Therapy Specialists
Our team of experienced cell and gene therapy professionals bring deep domain expertise to assist our clients in achieving their strategic and operational objectives
Services
We apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C>) field. Our team can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation.
We have a dozen commonly-requested services, listed below.
Watch this space biweekly for new case studies (select green buttons below).
The latest: a Comparabilty example (listed below under Process Dev & Comparability and Regulatory Support).
- Quantitative modeling
- CMO selection
- Technology transfer
- Facility design
- Failure analysis
- Comparability studies
- Process codification
- Process evaluation
- Process dev planning
- Method development
- Specification setting
- Qualification & validation
- Remediation
- Comparability testing
- Quality program strategy
- QMS gap analysis
- QMS gap filling
- Audits
- Regulatory strategy
- Document authoring and editing
- Global experience
- Critical path identification
- Project management
- Strategic project planning
- Stage-gating
- Strategic portfolio
assessment & analysis - Landscape analysis and competitive intelligence
- IP due diligence
- IP strategy
