Services
Our team of experienced professionals apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C>) field. We can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation.
Our range of a dozen service types is below; select one of the green case study buttons to review examples of working with us in these areas. Some case studies will be cross-referenced in more than area depending on crossover needs.
Watch this space biweekly for new case studies.
The latest: a Cell Therapy Due Diligence case study (listed below under Quality Systems and Financing & Diligence).
- 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
- QMS design and strategy
- QMS gap assessment
- Document authoring, review, and revision
- Supplier oversight
- Audits (see flyer below)
- URS development
- Landscape scan & gap analysis
- Custom device design
- Contract manufacturing management
- DHF & DMF development
- Regulatory strategy
- Document authoring and editing
- Global experience
- Preclinical strategy
- Study design and oversight
- Vendor selection
- Technical writing
- Critical path identification
- Project management
- Strategic project planning
- Stage-gating
- Strategic portfolio
assessment/analysis - Landscape analysis and competitive intelligence
- IP due diligence
- IP strategy
- Due diligence
- Message optimization
- Bespoke introductions
