Process Development

Design Group professionals deliver extensive experience in process development, specifically in the areas of product development, production technical support, validation, and technology transfer. Using multivariate analytical (MVA) techniques and tools, our professionals identify critical process parameters in order to successfully troubleshoot each project.  These process development capabilities enable Design Group to:

  • Analyze the process that identifies sources of variation,
  • Assess the size and impact of the variation, and
  • Implement programs to control the variation. 


Process Understanding is generally employed during the early product development stages, during scale-up activities, and prior to the initiation of validation. Expected results are waste reduction (e.g. rework and rejected material), elimination of non-value added activities (e.g. investigations and manual inspections), and enhancements in OEE metrics.

Design Group professionals apply Process Analytic Technology (PAT), along with existing data collection tools and statistical and multivariate analytical techniques in order to collect and analyze data, then design and implement a solution to meet each precise needs.

Process Development services focus on supporting:

  • R&D
  • Production Technical Services
  • Validation
  • Operational Excellence
  • Operations
  • Quality Assurance

The project profiles located to the right provide insight into our regulatory solutions experience.