Services

 

 

 

 

  • Contractor evaluation and selection
  • IND/NDA strategy and work plans
  • Technical project management to assure that:
    • Possible problems are found early so they can be solved quickly
    • Information is integrated across all contractors and within the company
    • Projects delays are minimized and known in advance
    • Possible difficulties are identified and back-up plans prepared in advance
    • Regulatory needs are identified
  • Compile and write CMC section for INDs and NDAs
  • “Temporary” highly skilled person to keep a project going in an emergency
  • Preparation for due diligence or other examination
  • CMC due diligence