Services

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 and thus far in 2022 we’ve added another. The two from last year are applicable to six of our twelve service areas, so rather than listing them underneath each of those six areas, we’re placing those links here for easy access. 

  • Method development
  • Specification setting
  • Method transfer
  • Qualification & validation
  • Remediation
  • Comparability testing
  • URS development
  • Landscape scan & gap analysis
  • Custom device design
  • Contract manufacturing management
  • DHF & DMF development
  • QMS design and strategy
  • QMS gap assessment
  • Document authoring, review, and revision
  • Supplier oversight
  • Audits (see flyer below)
  • Capacity modeling
  • Process and facility design
  • Project management
  • Process and project engineering services

  • Preclinical strategy
  • Study design and oversight
  • Vendor selection
  • Technical writing


  • Critical path identification
  • Project management
  • Strategic project planning
  • Stage-gating


  • Capacity planning
  • Cost-of-goods analysis
  • Build vs. Buy analytics


     

  • Needs assessment
  • Voice of customer surveys
  • Marketing strategy



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