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Chapter 6. Information Systems in Support of Pharmaceutical Development
Chapter 7. Title 21 CFR Part 11
Chapter 8. Format and Content of the CommonTechnicalDocument (CTD)
Chapter 9. Streamlining
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of the directives and guidelines for further information are provided.
The main focus of Chapter 4 is the content of the five modules that make up a CommonTechnicalDocument (CTD), or dossier. The implementation