Regulatory Affairs

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Strategy

  • Development Plan Review
  • CMC changes
  • Orphan drug designation
  • Expedited programs (FTD, BTD, etc)
  • Special Protocol Assessment (SPA)
  • Indications & labeling
  • Clinical holds
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Meetings

  • Agency meetings
  • Scientific advice
  • Advisory committee meetings
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Submissions

  • Clinical Trial Applications (IND, IMPD, CTA, CTN)
  • License applications (BLA, MAA, NDA)
  • Drug Master Files (DMF)
  • Amendments & supplements
  • Annual reports / DSUR
  • Risk Management Plans (RMP)
  • eCTD
  • US Agent services