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Electronic Publishing | eCTD

Electronic Publishing | eCTD

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
  • Regulatory Affairs Strategy
  • Electronic Publishing | eCTD
  • Medical and Regulatory Writing
  • Quality Assurance
  • Project Management
  • Electronic Trial Master File | eTMF

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After having worked with RPI for many years now, my expectations were naturally high. Once again, RPI’s outstanding staff delivered, on time, a clean submission. I deeply appreciate RPI’s depth of experience in terms of both regulatory strategy and publishing operations.
Jamie Cope
VP – Translational Medicine, Reset Therapeutics

RPI was founded in 1995 to serve the growing needs of small to mid-size pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Today, we are a highly-qualified and passionate team of experts with deep experience in health authority interactions and in the preparation of complex regulatory submissions requiring specific and strategic regulatory expertise.

Headquarters

8000 Jarvis Ave.
Suite 100
Newark, CA 94560

North Carolina

One Park Drive, Suite 150
Box 13608
Research Triangle Park,
NC 27709

San Diego

Aventine Building
8910 University Center Lane
Suite 400 San Diego, CA 92122

United Kingdom

250 South Oak Way
Green Park
Reading, Berkshire, RG2 6UG

Australia

Premier Research Australia Pty Ltd.
Ground Floor, 23 Milton Parade
Malvern VIC 3144

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Copyright 2020 Regulatory Professionals | All Rights Reserved
  • About Us
    • Our Story
    • Leadership
    • Senior Consultants
  • Services
    • Overview
    • Regulatory Affairs Strategy
    • Electronic Publishing | eCTD
    • Medical and Regulatory Writing
    • Quality Assurance
    • Project Management
    • Electronic Trial Master File | eTMF
  • Resources
    • Blog
    • White Papers
    • News
  • Careers
  • Contact
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