eCTD Services

Just need help with electronic submissions? We are dedicated to providing the same outstanding quality of service across all electronic submissions, be it an IND, NDA or ANDA submission, conversion to eCTD format or simply the maintenance of an existing application.

  • eCTD submission outsourcing
  • eCTD life cycle management
  • ESG for FDA
  • Regulatory writing and reviewing
  • Regulatory strategy consulting
  • SPL generation