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. 

Watch this space biweekly for new case studies (select green buttons below). The latest: a Device Development Regulatory Support case study is listed below under both Device Development 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
  • 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
  • Regulatory strategy
  • Technical writing/editing
  • Gap analyses
  • Meeting assistance
  • 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

In honor of our Twitterversary, we give you...our first Dark Horse video! Voiceover courtesy of our intrepid leader, @ADaviesDHCG 🙌👏🎉
If you don't already know and love us, take 56 seconds out of your day to get acquainted.😉https://vimeo.com/469023007

It took only one pivotal class for Houria Bachtarzi, this week's #DHCinperson, to make the decision to devote her career to the field of C&GT. She is driven to find ways to make the impossible possible (and to be instrumental in saving lives as a result). http://bit.ly/Houriainperson

It's Day 3 at #Mesa20 and we're looking forward to today's live panel discussing the lasting #Covid19 impact on cell and gene therapy chaired by @darkhorsecagt. Interested in meeting the team? Request via the partnering tool and one of the team will be in touch!🧬🤝🏆 @alliancerm

Are you at Meeting on the #MESA20 this week? Be sure to attend @ADaviesDHCG's session tomorrow (Wed, Oct 14), titled "The Lasting CoVID-19 Impact on Cell and Gene Therapy."
12pm – 1pm PT / 3pm – 4pm ET

We use cookies to help give you the best experience on our website. By continuing you agree to our use of cookies.