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 (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. Commonly-requested 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

Today, as part of our biweekly #gettoknowDHC offering, meet Sara Mills, Senior Consultant: process dev and tech transfer specialist, yoga devotee, and competitive sailor. #DHCinperson https://darkhorseconsultinggroup.com/sara-mills-in-person

CEO @ADaviesDHCG on the urgent need for a paradigm shift in SARS-CoV-2 testing. “We are doing the wrong test.” #SftHM #darkhorsepredicts #darkhorsecorrects #themoreyouknow #COVID19 #coronavirus https://bit.ly/thewrongtest

Today was Day 1 for our newest principal, Katie Miller, who adds add’l senior expertise in both Analytical Dev & Quality Control to our group. She was with us via Zoom b/c of this surreal new reality, but Katie, we look forward to welcoming you in person! https://bit.ly/DHCKatie

.@michaeladeniya speaks with with our CEO, @ADaviesDHCG, as @Phacilitate coordinates a conversation about remote work and our industry's ongoing adaptations during these unusual times.

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