While our primary focus is on submissions to the US Food and Drug Administration (FDA) and Health Canada, our experts have authored and/or reviewed registration dossiers submitted to the European Medicines Agency, MHRA, TGA, and several global health authorities (HAs). 

  1. Investigational New Drug Applications (INDs)
  2. Clinical Trial Applications (CTAs)
  3. New Drug Applications – 505(B)(1) and 505(B)(2)
  4. New Drug Submissions (NDS)
  5. Marketing Authorization Applications (MAA)
  6. Responses to FDA and HA requests for information
  1. Pre-IND meetings
  2. End-of-Phase II meeting
  3. Pre-NDA and Pre-NDA CMC meetings
  4. Meetings to address Complete Responses from the FDA and other global HAs

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