Shadle Consulting Services
Good Science is Good Compliance
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::  Process Development  ::  Analytical Development  ::
Our staff has a broad range of technical expertise that can help you through a variety of development challenges.
  • Experience in large scale chromatography, cell culture, filtration, and fill / finish.
  • Do you need assistance with drafting and submitting a comparability protocol?  Post-approval change?  IND update?
  • Do you need guidance for your process validation?  Which of your DOE studies can be used?
  • Do you know when to set specifications?  When do you have enough data?  When to add or remove a test?
  • We can help you implement QbD, How to apply ICH Q8-Q9-Q10--  Quality Systems, Design Space
  • Should you in-source or out-source? 
Process Transfer and Assay Transfer
  • When do you transfer your process from clinical to commercial?
  • We can assist with internal transfer or to a CMO (Contract Manufacturing Operation).
  • Transfer protocols, reports, and data analysis.