eCTD Submission Services:

RPI has been a trusted eCTD vendor for small to mid-size pharmaceutical, biopharmaceutical, and medical device companies since 1995. RPI professionals who prepare the electronic dossier are the first-line assurance that the sponsor’s documentation is prepared in accordance with electronic requirements of regulatory bodies worldwide with the overall goal of facilitating Agency review and approval of the application. RPI’s electronic publishing staff assure on-time submission that meets the highest quality standards, especially for clients with little or no experience in preparing an electronic submission. RPI accomplishes this through a highly collaborative effort that results in the best possible eCTD publishing and submission service to our clients. RPI’s eCTD submission support includes:

  • eCTD-ready templates for authoring submission content
  • Document level services, including document formatting and PDF generation, bookmarking and hyperlinking documents, CRFs, datasets
  • Preparing eCTD submission-ready Clinical Study Reports (ICH E3 compliant)
  • eCTD conversion of paper applications
  • Submission planning and management
  • eCTD build with full validation performance
  • Technical contact for FDA submission inquiries
  • Submission lifecycle management
  • Full regulatory operations service

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