Services

Our team of experienced professionals 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
  • Root cause analysis
  • Process correction
  • Quality program strategy
  • QMS gap analysis
  • QMS gap filling
  • Audits
  • Regulatory strategy
  • Document authoring and editing
  • Global experience