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

As befits someone who has been working in Quality Systems since the 90s, Rosemarie Logan concludes our #practiceexpertweek by walking us through the intricacies of the discipline & the pivotal role that a Quality Practice Expert can play in maximizing success in C&GT manuf. (1/2)

Ian Pardo, Practice Expert in Quality, is the featured face of today's #practiceexpertweek profile! Read about what it takes to become an EU Qualified Person, how he uses an understanding of human behavior to provide top-notch Quality support, and which flowers (1/2)

Today in DHC's #practiceexpertweek we meet Donald Fink, a legend of the FDA. Dr. Fink takes the concept of a Practice Expert to the next level ("Master" level, in fact). Read some of his serendipitous encounters, including how he parlayed a conveniently located ad in (1/2)

*looks around quizzically*
Where did Wednesday go?🤷🗓️
Since time has no meaning in global-pandemic-land, we're going to keep that next #practiceexpertweek profile in our pocket until tomorrow. Trust us, though, it'll be worth the wait!🕰️😉

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