Services

Our team of experienced professionals apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C&GT) field.  Our team can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation. Our range of services include:

  • 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
  • Quality program strategy
  • QMS gap analysis
  • QMS gap filling
  • Audits
  • URS development
  • Custom device design
  • Engineering oversight
  • DHF & DMF development
  • Regulatory strategy
  • Document authoring and editing
  • Global experience
  • Preclinical strategy
  • Gap analysis
  • De novo design
  • Technical writing
  • Critical path identification
  • Project management
  • Strategic project planning
  • Stage-gating
  • Needs assessment
  • Voice-of-customer surveys
  • Marketing strategy
  • Strategic portfolio
    assessment/analysis
  • Landscape analysis and competitive intelligence
  • IP due diligence
  • IP strategy
  • Due diligence
  • Message optimization
  • Bespoke introductions

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