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’ll be releasing 20 case studies (select green buttons below) to provide you with concrete examples of how our expertise can support your business. The latest: a Market Research case study, is listed below in the Market Research section. 

  • 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
  • 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

Oliver Ball, our new Business Development Mgr, is this week's #DHCinperson! Read about his first impressions after joining Dark Horse, his sense of the industry dynamics at play, and how he captured this amazing shot: ⬇️https://bit.ly/Oliverinperson

Looking for something to do this weekend? (The long🦃 weekend, if you're U.S.-based?) You could always refresh your résumé/CV.🤔We've hired three extraordinary new folks in the last six weeks & our call for all levels, all locations continues! https://darkhorseconsultinggroup.com/careers/

Today we welcomed Heather Todd, our newest Senior Consultant, along with her two decades of CMC experience, ranging from R&D to clinical phase and commercial manufacturing. Heather, we're so glad to have you and your expertise on board! https://bit.ly/HeatherTodd

Our newest #DHCcasestudy focuses on the Market Research aspect of #DHCservices. To successfully enter this space, MR should be done by a firm that is extensively versed in the field's technical complexities. This example features a complete MR work-up. https://bit.ly/DHCcasestudies

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