DHC during the CoVID-19 pandemic: Most DHC services are available remotely but we’re building new alternatives when needed to ensure that we continue to help you move your program forward. For example, we now offer a Virtual Remote Audit. If that is of interest, or if you wish to request other remote services, please request a consultation.

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.


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. 
During 2020, we released 20 case studies (green buttons below) to provide you with concrete examples of how our expertise can support your business. The last case study of the year, Quantitative Modeling May Yield the Unexpected (aka Quant Model #2), is listed below in two applicable service areas: Manufacturing Support and Quantitative Modeling.

  • Method development
  • Specification setting
  • Method transfer
  • Qualification & validation
  • Remediation
  • Comparability testing
  • Capacity planning
  • Cost-of-goods analysis
  • Build vs. Buy analytics

  • QMS design and strategy
  • QMS gap assessment
  • Document authoring, review, and revision
  • Supplier oversight
  • Audits (see flyer below)
  • URS development
  • Landscape scan & gap analysis
  • Custom device design
  • Contract manufacturing management
  • DHF & DMF development
  • Preclinical strategy
  • Study design and oversight
  • Vendor selection
  • 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

This week brings us our newest Consultant, Jacob Staudhammer! Jacob comes to Dark Horse with experience in process development and characterization of gene therapy viral vectors, from early pre-clinical development to design of PPQ campaigns. A hearty DHC welcome to you, Jacob!

Our first annual lookback is available online (and shortly, in print as well)! Visit https://darkhorseconsultinggroup.com/2020-lookback
to read what 2020 looked like from our POV. And from there, you can also sign up to receive our newsletter, The Quarter Horse; Issue 1 forthcoming at the end of Q1.

Last night on what Founder and CEO @ADaviesDHCG aptly termed "Happy Eve of Not #JPMorgan," he put together a #dhcpredicts top-ten list that was simply too good to consign to the eventual oblivion of the Twitterverse.
Here it is: http://bit.ly/ADlooksahead2021

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