Our team of experienced professionals apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C&GT) 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
  • Capacity planning
  • Cost-of-goods analysis
  • Build vs. Buy analytics
  • 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
  • Needs assessment
  • Voice-of-customer surveys
  • Marketing strategy
  • Strategic portfolio
  • Landscape analysis and competitive intelligence
  • IP due diligence
  • IP strategy
  • Due diligence
  • Message optimization
  • Bespoke introductions

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