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

oh hey, don't forget: we're still hiring:
If you're a star/rising star in C&GT & you want to work for the best consultancy there is, dust off your résumé/CV & send +cover letter to careers@darkhorseconsultinggroup.com. PDF preferred.

How great does our C-suite look, together in real life? Three cheers for (L-R) Ryan Chavez (CFO), Anthony Davies (CEO), and Katy Spink (COO)!

And the good news continues! Today begins the tenure of DHC's newest Principal, Sanjin Zvonić. We're delighted to have him aboard, along with his strong background in stem cell biology and cell therapy CMC development and manufacturing. Dobrodošao! https://darkhorseconsultinggroup.com/sanjin-zvonic/

Our team is enriched +2 today, beginning with CFO Ryan Chavez: https://darkhorseconsultinggroup.com/ryan-chavez/
A CFO as well as a law professor, Ryan brings with him extensive experience in supporting private & public businesses in the biopharma space. We're thrilled to have him with us. Welcome!

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