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DRUGS


U.S. FDA Prescription Drug Establishment Registration & Listing Requirements

A Prescription Drug is a human drug that is not safe for use except under the supervision of licensed medical practitioner. MEDERA assists companies with the following Prescription Drug requirements:

  • U.S. FDA Prescription Drug Establishment Registration
  • U.S. FDA Prescription Drug Listings and Label Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA Prescription Drug Labeling and Ingredient Requirements