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.

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. 
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

The ILAP: does it portend the UK becoming an export hub in the cell and gene space? CEO @ADaviesDHCG, Principal @RobAllenDHCG, and Practice Expert, Quality @IanPardoDHCG speculate on the possibility. http://bit.ly/DHCconsiderstheILAP

Did you get Issue 1 of our Quarter Horse newsletter? If not, you missed a Q&A b/t COO Katy Spink and Master Practice Expert Don Fink (formerly of the FDA) on the pattern of regulatory challenges we've been seeing, possible ways to address them, + more! http://bit.ly/QuarterHorse1

No fooling!🤓(gotta say it, it's April 1⃣, can't be too careful...) You're not gonna want to miss this #BPIwest fireside chat featuring our own @ADaviesDHCG and @NovartisGene's Robert Hodge.
https://www.linkedin.com/posts/sarah-lintern-48164b36_bpiwest-genetherapy-manufacturingtechnology-activity-6783073767292727296-X2Hx

It's the 1st Q new-hire DHC round-up! 2021 has thus far brought us three additional exceptional folks:
- Don Fink, Ph.D., as Master Practice Expert, Regulatory. You'll know Don from his 25+ years of US FDA-regulatory review experience as a CMC SME. (1/3)

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