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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 2012-1

Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review

Sam Salek, Andrea Mallia-Milanes, Neil McAuslane [...]

Therapeutic Innovation & Regulatory Science

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First published 2001-1

Preclinical Considerations for Regulatory Submissions

Paul Baldrick

Therapeutic Innovation & Regulatory Science

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First published 1999-1

Facets of User-Friendliness: From Format to Content in Regulatory Submissions

Jürg P. Seiler

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-3

Evolving Global Regulatory Science Through the Voluntary Submission of Data

Elizabeth Gribble Walker, Martha Brumfield, Carolyn Compton [...]

Therapeutic Innovation & Regulatory Science

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First published 2000-7

Regulatory Submissions: From CANDA/CAPLA to 2002 and Beyond

Ross Raymond, Susan Galle, William Collom

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 2014-06

Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership

Peter C. Johnson, Tim A. Bertram, Neal R. Carty [...]

Tissue Engineering Part A: Research Advances

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First published 2000-7

Transitioning to Electronic Publishing

Melissa A. Maynard

Therapeutic Innovation & Regulatory Science

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Review article

First published 2026-5

A comprehensive review of humanized mice applications in regulatory submissions for cell and gene therapy products

Giovanni Pellegrini, Lucia Minoli, Sara Degl’Innocenti [...]

Veterinary Pathology

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