Our team of experienced professionals apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C&GT) field. We can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation.

Our range of a dozen service types is below; select one of the green case study buttons to review examples of working with us in these areas.
To view these organized by case study rather than by service type, please visit our page of case study examples.

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
  • Landscape analysis and competitive intelligence
  • IP due diligence
  • IP strategy

We use cookies to help give you the best experience on our website. By continuing you agree to our use of cookies.