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.

We have a dozen commonly-requested services, listed below. 

Watch this space biweekly for new case studies (select green buttons below). 
The latest: a Comparabilty example (listed below under Process Dev & Comparability and Regulatory Support). 

  • 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

Our second #DHCcasestudy is up for your perusal. Choose the green case study button to learn about the comparability side of #DHCservices (with a crossover into regulatory support)! https://bit.ly/DHCcomparability

Thank you, @Phacilitate, for this video from the super-plenary back in Jan, hosted by our own @ADaviesDHCG. ...oh, sorry, got lost in the fond memories of those days when we used to see other humans IRL.😁😢
Here's CF advocate Joan C. Finnegan: http://bit.ly/Jan2020WSCSummitsuperplen1of4 👏👏👏

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

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