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

News & Media

COGS crisis: Cell therapy sector must rethink CMC says expert

by Gareth Macdonald The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process” mind-set says Anthony Davies, CEO of Dark Horse Consulting. Cell and gene therapies have attracted a lot of attention in recent years. In part this is because drugs like Yescarta, Kymriah and Zolgensma have been approved

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Arcline Investment Management And Dark Horse Consulting Group Enter Into Strategic Partnership

SAN FRANCISCO /PRNewswire/ — Arcline Investment Management (“Arcline”), a growth oriented private equity firm with $1.5 billion of capital under management, today announced the formation of a strategic relationship with Dark Horse Consulting Group (“Dark Horse” or “the Company”).  Taking the form of an investment in Dark Horse, Arcline’s commitment enables the Company to significantly

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