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1-10 of 22 results for Electronic regulatory submissions

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

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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

Select article: Transitioning to Electronic Publishing

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Other

First published 2000-7

Transitioning to Electronic Publishing

Melissa A. Maynard

Therapeutic Innovation & Regulatory Science

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

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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

Select article: The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry

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Other

First published 1998-7

The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry

Ronald D. Fitzmartin

Therapeutic Innovation & Regulatory Science

Select article: Leveraging Technology to Increase Efficiency and Quality for Regulatory Submissions

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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

Select article: Creating eCTD Applications

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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

Select article: Standardization of Report Formats for Chemistry/Pharmacy Documents

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Research article

First published 1996-1

Standardization of Report Formats for Chemistry/Pharmacy Documents

Marie Ostman

Therapeutic Innovation & Regulatory Science

Select article: Electronic common technical document submission with analysis using R

Open access

Research article

First published 2023-2

Electronic common technical document submission with analysis using R

Yujie Zhao, Nan Xiao, Keaven Anderson [...]

Clinical Trials

Select article: Toward a Comprehensive CDISC Submission Data Standard

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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

Select article: CANDA Overview: What Should a CANDA Look Like?

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Research article

First published 1993-4

CANDA Overview: What Should a CANDA Look Like?

William P. Accomando

Therapeutic Innovation & Regulatory Science

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