Pharmaceutical drug development; Drug delivery systems; Scientific writer & editor

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Independent Consultant

     Judy Senior, Ph.D. has extensive experience in pharmaceutical drug development especially with injectable drug products. She works with small molecules & biologicals with expertise in numerous types of formulations and drug delivery systems including sustained release, poorly water-soluble drugs, siRNA, proteins, and nanotechnology. In addition to shepherding new drug products through formulation development and manufacturing, Dr. Senior writes CMC and Pharm/Tox sections of IND/IMPDs and other regulatory sections and documents including NDAs.



 

 

 

 

Areas of expertise include:

  • CMC Consulting
  • Project/Program management
  • Sterile manufacturing
  • Technology assessments
  • Due Diligence
  • Drug Development Strategic Planning
  • GMP Manufacturing Site Audits
  • Analytical Laboratory Site audits
  • Regulatory submissions
  • More...