PharmaLex network of resources and experience utilized to guide the client to success

  • CMC subject matter expertise for gene therapy was provided to effectively map eCTD locations of legacy documents
  • Anchor eCTD submissions were established and dispatched through the FDA electronic submissions gateway to begin the eCTD submission management
  • Experienced regulatory operations managers guided the client regarding the nature of lifecycle operators and eCTD granularity
  • Technical support was provided for eCTD templates