eREG manages your authoring templates and makes sure you only use approved templates that match your document type. You can create a new document in just a few clicks - most metadata is auto-populated.
eREG provides you with a dashboard for each product, summarizing clinical and nonclinical studies, drug product and substance, excipients, and regulatory applications. One click takes you to related documents.
eREG provides multiple navigation options including folder structures and filtered searches. Publishers can quickly locate the content needed for a particular eCTD section or study and drag into a publishing tool.
eREG comes configured out of the box for the US, EU, Japan, Canada, Switzerland, Australia, South Africa, Thailand, and Saudi Arabia.
Need to deliver your documents to a publishing partner? eREG allows you to create a zip file with the relevant documents in PDF format (where applicable) to streamline the process.
It’s simple to start or participate in a review or approval workflow. When the electronic signature option is used, approvers are prompted to sign, and after all approvals have been received eREG generates a 21 CFR Part 11 compliant signature page. Workflow initiators can manage their workflows, adding and removing participants and terminating workflows if needed.
eREG is part of the IQVIA Regulatory Platform, which includes the ACUTA ARIM solution. This solution includes modules for: