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 field. Our team can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation. Common services include:

  • Process codification
  • Process trending
  • Gap analysis
  • Process development planning
  • URS development
  • Custom device design
  • Engineering oversight
  • DHF & DMF development
  • Critical Path Identification
  • Project Management
  • Strategic Project Planning
  • Stage-gating
  • Due diligence
  • Message optimization
  • Bespoke introductions
  • CMO selection & oversight
  • Technology transfer
  • Person-in-plant
  • Facility design
  • Preclinical strategy
  • Gap analysis
  • De novo design
  • Technical writing
  • Quality program strategy
  • QMS gap analysis
  • QMS gap filling
  • Audits
  • Regulatory strategy
  • Document authoring and editing
  • Global experience

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