Medical Devices

Process Development

  • New product strategic planning- taking your product from concept to clinical trials (also see Strategic Planning)
  • Identification of contract manufacturers and product introduction or technology transfer
  • Statistical experimental design and data analysis
  • Experience with scale up and optimization of relevant processes, such as
    • Solids handling, grinding, transport
    • Solid/Liquid Extraction
    • Liquid/Liquid Extraction
    • Chemical Modifications
    • Solids Blending
    • Filtration
    • Precipitation
    • Crystalization
  • Composing and reviewing protocols related to development and characterization efforts for new or established processes
  • Experience with various active ingredients and final dosage forms, including:
    • Plant-derived chemicals
    • Synthesized small molecules
    • Controlled release systems, such as PLGA, polyanhydrides, and PEG-PLA