Work Locally - Publish Globally
eREG comes configured out of the box for the US, EU, Japan, Canada, Switzerland, Australia, South Africa, Thailand, and Saudi Arabia.
Produce and Assemble Submission Ready Content
• Enforces ICH and Health Authority required granularity
• Automatic generates compliant PDFs
• Automatically organizes your documents in a CTD-based structure ready for publishing
• Two to four weeks from start to finish
• Training sessions and materials included
• Complete UAT package including URS, Test Plan, Test Scripts, and Test Report
Are you ready for the eCTD Mandate?
Insight into readiness of documents needed for upcoming submissions
- Use placeholders to gain insight into required content
- See the status of all documents at a glance – including who is authoring, reviewing or approving them
Streamlined authoring, review and approval processes
- Find your document type with just a few clicks
- Create from template or upload partially completed document
- Send for review, approval or eSignature
Support for submission assembly and publishing
If you publish submissions in-house:
eREG is tightly integrated with eCTD taxonomy and metadata. As documents are created, they are tagged with CTD section, file tag, and other metadata that allows submission publishers to locate documents quickly and drag into submission outlines.
If you outsource submission publishing:
Sponsors can choose to provide their publishing partners direct access to designated products in eREG. Sponsors can create standard or custom export packages to deliver to publishing partners.
Integrations with other document and data sources
- Pull eTMF documents from Wingspan eTMF
- Upload information about products, substances and studies
Submission-ready documents in all regions
- Enforces ICH and Health Authority required granularity
- Automatic generates compliant PDFs
- Automatically organizes your documents in CTD format ready for publishing
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 – or upload a document already created outside the system.
eReg provides you with a product dashboard for each study. The dashboard summarizes clinical and nonclinical studies, drug product and substance, excipients, and regulatory applications. One click takes you to related documents.
Review and Approval
It’s simple to start or participate in a review or approval workflow. When the electronic signature option is used, approvers are prompted to enter their credentials, 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.
One Click Export
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.
Navigating the Product Dossier
eReg provides multiple navigation options including folder structures and eBay-like filtered searches. Publishers can quickly locate the content needed for a particular eCTD section or study, and drag into a publishing tool.