Dossier and submission records
Product scope under development; confirm the supported workflow and qualification evidence for the exact package.
Enterprise operations
Red Regulatory Affairs
Dossier, commitment, variation, submission and regulatory information lifecycle management. Independent RED product with separate Vendor, Customer Administrator and End User editions in development.
A modular approach
Explore what fits your workflow.
Variation and commitment tracking
Product scope under development; confirm the supported workflow and qualification evidence for the exact package.
Regulatory review and submission
Product scope under development; confirm the supported workflow and qualification evidence for the exact package.
Three separate editions
Vendor licence authority, Customer Administrator configuration and scoped End User access; independent product identity and installation data.