Pharmaceutical Industry Articles & Reports - Page 4

Learn the key differences between the Common Technical Document (CTD) and electronic CTD (eCTD). This guide covers the evolution from paper to the XML-based eCT

Learn the complete eCTD publishing process for regulatory submissions. This guide explains the eCTD format, XML backbone, workflow, and global requirements from

A complete guide to the IND & NDA eCTD submission process. Learn the eCTD format, CTD modules, FDA requirements, and the transition from eCTD v3.2.2 to v4.0.

Get an in-depth comparison of eCTD software for regulatory submissions. This guide analyzes top platforms like Veeva & EXTEDO on features, pricing, & eCTD v4.0

Learn about eCTD regional variations for global regulatory submissions. This guide compares Module 1 requirements from the FDA, EMA, Health Canada, and more.

Learn the EMA eCTD Gateway specifications for regulatory submissions. This guide explains the technical architecture, AS2 protocols, validation, and file requir

Learn about common eCTD validation errors that lead to submission rejection. This guide covers FDA and EMA rules, error types, and strategies for first-pass com

Learn the FDA's mandatory eCTD submission requirements, including key deadlines, technical standards, and the transition from eCTD v3.2.2 to v4.0 for NDAs, BLAs

A guide to regulatory submission quality control (QC). Explore best practices for eCTD dossier checklists to ensure compliance and avoid costly FDA/EMA rejectio

Learn the essential eCTD validation requirements for regulatory submissions to the FDA and EMA. This guide covers technical specifications, business rules, and

Learn the technical requirements for eCTD software submissions to the FDA, EMA, and Health Canada. This guide covers validation rules, mandates, and eCTD v4.0.

Learn how integrating eCTD publishing software with a Document Management System (DMS) streamlines pharma regulatory submissions and improves data consistency.

Learn about Veeva Vault RIM cost for small biotech. This guide analyzes pricing models, licensing fees, implementation costs, and Veeva Basics for emerging biop

A technical guide to eCTD publishing software for regulatory submissions. Compare top tools like LORENZ, EXTEDO, and Veeva for eCTD v4.0 compliance and validati

Explore key strategies for accelerating pharma regulatory submissions. Learn about expedited pathways, process redesign, and the role of AI in shortening drug a

Learn what eCTD viewer software is and why it's critical for regulatory submissions. This guide covers key features, technical capabilities, and tools.

Learn how Regulatory Information Management (RIM) systems help biotech firms manage compliance. This guide details core capabilities, submission planning, and t

Explore key challenges in pharmaceutical regulatory submissions, from legacy eCTD issues and CMC gaps to the rise of AI and structured data for faster drug appr

Learn what Approved WeChat on WeCom is and how it enables compliant pharmaceutical engagement with HCPs in China. Explore its features, CRM integration, and rol

Learn the complete syntax of Veeva Vault Query Language (VQL). This guide covers SELECT, FROM, WHERE, and FIND clauses, API usage, and practical examples.

Learn about Exeevo CRM for the life sciences industry. This technical guide covers its platform architecture, AI features, and use cases on Microsoft Dynamics 3

An educational analysis of the Syneos Health CRM strategy. Explore its "Dynamic Assembly" model, key tech partners like Veeva & Microsoft, and its impact on HCP

Learn about m3.com, Japan's dominant physician network with 90% market share. This analysis compares its CRM and content model to LinkedIn and WebMD.

An educational profile of Close-Up International. Explore its history since 1968, key services in pharma data and CRM, and market position vs. Veeva & Salesforc