Pipeline EDM™ includes a company-wide central repository for all documentation and data, and can extract information when building eCTD submissions.
Document Management
Pipeline EDM™ integrates all work functions in the organization, and provides a central repository for all data and documentation throughout the drug product life cycle. With a single central repository, managing the document life cycle, including review cycles, version control, and audit trails, becomes effortless through automation. Document types based on the current CTD format are defined and included.
Electronic Submissions
Building electronic submissions for regulatory authorities is a more streamlined and efficient process, resulting in faster milestone achievement. Regulatory submissions and related correspondence can be managed in Pipeline EDM™. The eCTD can be created and the submission life cycle can be managed in addition to managing legacy paper submissions.
