Part of IQVIA’s RIM Smart platform, this SaaS solution streamlines regulatory submission content creation, review, and approval. It enhances collaboration, reduces errors, and ensures GXP compliance. Features include 340+ preformatted templates, auto-classification, labeling workflow integration, and submission-ready PDF generation. It maintains a single authoritative content source, synchronizing global metadata for submissions and labeling. Regulatory-ready with FDA 21 CFR Part 11 compliance, it boosts efficiency with automation, real-time progress tracking, and reduced validation burdens, transforming compliance into a strategic advantage.

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