FDA Submission

FDA Registration, US Agent Representation and ANDA/DMF Compilation

  • Registers your domestic (US) or foreign (non-US) active pharmaceutical ingredient (API) or drug manufacturing facility with the FDA
  • Advises you on how to complete the mandatory FDA registration number process, and Serves as the mandatory US agent required for all foreign API or drug manufacturing facilities under US FDA Law, and does so confidentially.
  • Includes all your products in the registration as part of our US Agent Compliance
  • Assists you with applying for and obtaining the Pre-Launch Activities Importation Request (“PLAIR”) for your drug product prior to FDA approval
  • Monitors all registration laws and regulations and keeps you informed of changes that might affect your US FDA registration
  • As your US Agent, we act as a liaison between the FDA and you company – managing and responding to all alerts, notices and communications, thereby ensuring that you maintain your compliance with US FDA Laws
  • Confidentially transmit all legally required notices and communications between the FDA and your organization/facility.
  • Help you in compilation of ANDA or DMF, Amendments, Supplements, and Annual Reports