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![PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar](https://d3i71xaburhd42.cloudfront.net/30903f1fc51c4917a2877b9cf3756ccc7fc6425a/11-Table1-1.png "PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar")
PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar
The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1
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![PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar](https://d3i71xaburhd42.cloudfront.net/30903f1fc51c4917a2877b9cf3756ccc7fc6425a/16-Table2-1.png "PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar")
PDF] Between Standardisation and Flexibility – Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe | Semantic Scholar
Electronic Common Technical Document Specification
What Is Regulatory Dossier and What Does It Contain? - The Kolabtree Blog
PDF) Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format
