Regulatory Documents and Submissions


Experienced in the Coordination, Writing, Review, and Approval 

of all your Regulatory Documentation Requirements. 


  • Facility Registration Assistance
  • Investigational New Drug Applications (IND) Preparation
  • Coordination of New Drug Applications (NDA)
  • Warning Letter and Form 483 Response Assistance 
  • Coordination of EU Clinical Trial Authorization (CTA)
  • Coordination of other Regulatory Documentation for world-wide Registration
  • Clinical Label Review and Approval