Pharma Sprint 30 - eCTD Skill Burst (eBook, ePUB) - Renganathan, Ragupathy
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Pharma Sprint 30 eCTD Skill Burst is a practical guide designed for regulatory affairs professionals, submission specialists, and pharmaceutical teams to master the electronic Common Technical Document (eCTD). Covering 30 essential skills, the book provides comprehensive insights on module structure, sequence management, XML validation, audit trails, lifecycle management, regional requirements, QC checks, automation tools, and regulatory interactions. Real-world examples and case studies illustrate how to manage large submissions, handle supplements, respond to queries, and maintain…mehr

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Produktbeschreibung
Pharma Sprint 30 eCTD Skill Burst is a practical guide designed for regulatory affairs professionals, submission specialists, and pharmaceutical teams to master the electronic Common Technical Document (eCTD). Covering 30 essential skills, the book provides comprehensive insights on module structure, sequence management, XML validation, audit trails, lifecycle management, regional requirements, QC checks, automation tools, and regulatory interactions. Real-world examples and case studies illustrate how to manage large submissions, handle supplements, respond to queries, and maintain compliance across all phases of the eCTD lifecycle. This book equips readers with practical strategies for error-free, timely, and audit-ready submissions, enhancing regulatory confidence and operational efficiency.

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