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 first 2021 case study, Remediation of CRL issues for BLA Resubmission, is applicable to six of our twelve service areas so we’re placing it up top, here, for clear and easy access.

  • 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

Do you have ??s about the C&GT regulatory space (either fr the POV of the tx developer or the supplier side)? You're not alone! #ICYMI, this panel of experts
(including DHC CEO @ADaviesDHCG) are here to help, in this on-demand webinar from @Bio_Insights https://bit.ly/BioInsightsOnDemandRegulatory

If you thought we were done hiring for this Q, you would be wrong b/c we've got two more awesome folks to welcome. 😀 Today is Sr Controller Sheryl Andersen's 1st day & we're so excited to have her depth of experience in financial/acct ops in our stable! https://bit.ly/DHCteam

Do you want to be like Josh? If you have the skillset and want to be a part of the amazing #DHCanalyticaldev team, then you're in luck, because we have an Analytical Consultant position open right now! https://bit.ly/ACSCposition

There's a member of the #DHCdeepdive #DHCanalyticaldev team that you haven't met "in person" yet, though he's been w/ us for 1.5 years. Let's remedy that! Meet Joshua Beckett: fosterer of puppies, grower of plants, boarder of wakes, analyzer of data. http://bit.ly/Joshinperson

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