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. 

Watch this space biweekly for new case studies (select green buttons below). The latest:
a Regulatory Strategy case study (listed below under Process Development & Comparability as well as Regulatory Support). 
 

  • 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
  • Regulatory strategy
  • Technical writing/editing
  • Gap analyses
  • Meeting assistance
  • 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
  • Due diligence
  • Message optimization
  • Bespoke introductions



Whether you need an engineer with experience in device design & instrument dev, someone who can walk you through regulatory documentation, manufacturing methods, & process optimization, or...a certified beer judge, Consultant Vince So is your #DHCinperson! https://bit.ly/Vinceinperson

This latest #DHCcasestudy highlights international regulatory #DHCservices, including strategic guidance for and technical writing of filings in multiple jurisdictions.
See more at https://bit.ly/DHCcasestudies.

DHC Consultant Andrew Steinsapir is this week's featured #DHCinperson. Learn about how theatre and improv mesh with his ChemE degree and the two questions he asks himself in each new engagement. Plus: what drives him to focus on C&GT. https://bit.ly/Andrewinperson

It is Senior Consultant Houria Bachtarzi's first day here at Dark Horse and we are thrilled to have her & her 14+ years of extensive expertise in gene engineering, genetically modified replication-deficient and replication competent viral vectors on board! https://darkhorseconsultinggroup.com/houria-bachtarzi/

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