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IND Preparation

  • Meeting requirements of 21 CFR 312
  • Coordination of receipt, editing, review and revision of IND documents
  • Assembling, indexing, copying and distributing documents
  • Follow-up to FDA—review comments and preparation of a response
  • Prepare amendments and supplemental submissions

 

 

 

 

 

 

 

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     Last Updated Jan 25, 2010

 

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