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.
To view these organized by case study rather than by service type, please visit our page of case study examples.

Watch this space biweekly for new case studies. The latest: a Device Development Regulatory Support case study is listed below under both Device Development 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
  • Method transfer
  • 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
  • Technical writing/editing
  • Gap analyses
  • Meeting assistance

  • 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

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