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 areas 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 to provide concrete examples of how our expertise can support your business.
In 2021 we added two more case studies to the bank. Both of them (Remediation of CRL issues for BLA resubmission, and Embedded early for de novo support) are applicable to six of our twelve service areas, so we’re placing those links 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
  • Landscape analysis and competitive intelligence
  • IP due diligence
  • IP strategy

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