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Research article

First published 2012-1

The Electronic Common Technical Document (eCTD)

Andreas Suchanek, Herwig Ostermann

Therapeutic Innovation & Regulatory Science

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Research article

First published 2006-1

Creating eCTD Applications

Kim Nordfjeld, Vito Strasberger

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 2009-7

Electronic Common Technical Document Implementation in Japan

Kiyohito Nakai, Yasuhiro Araki, Daigoro Ebina [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-9

Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification

Sandra Krogulski

Therapeutic Innovation & Regulatory Science

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Other

First published 2007-5

Toward a Comprehensive CDISC Submission Data Standard

Wayne R. Kubick, Stephen Ruberg, Edward Helton

Therapeutic Innovation & Regulatory Science

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Other

First published 2010-1

Leveraging Technology to Increase Efficiency and Quality for Regulatory Submissions

Patricia Sichort, Teresa Booth-Genthe

Therapeutic Innovation & Regulatory Science

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Research article

First published 2001-8

Electronic submission of regulatory information in support of marketing applications for medicinal products. The eCTD: Work in progress

Stan van Belkum

Pharmaceuticals Policy and Law

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Research article

First published 2006-02

Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Biotechnology Law Report

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Other

First published 2008-1

Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions

E. Gaussens, S. Daniel, E. Messiaen [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2006-3

The Regulatory Department: An Agent for Knowledge Sharing and Process Change

Steve Scrace

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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