1. Document Collection: Regulatory publishing begins with the collection of documents from various teams (or external systems we can connect to). These documents are typically in various formats, such as Microsoft Word or Adobe PDF. Our built-in document format automation will QC and Auto-Fix documents as per country specific requirements
2. Document Preparation: The collected documents are then prepared according to the regulatory requirements and guidelines. This involves formatting, reviewing, and editing the documents to ensure consistency and accuracy Our tool will handle all these steps as part of document automation process to save you time
3. Document Publishing: The prepared documents are then converted into a submission-ready format (using our built-in “submission ready” functionality for FDA, EU NBs and other HAs), and compiled into a submission package.
4. Submission Tracking: Regulatory publishing also involves tracking the status of the submission with the regulatory authorities. This involves monitoring for acknowledgments, requests for additional information, and other communication.
5. Life-Cycle Updates: Once the submission has been approved, regulatory operations publishing also includes updating the regulatory authorities with any changes to the product, such as label updates or manufacturing changes. Our detailed life-cycle management handles both document level operations and correspondence aspects
6. Collaboration: Regulatory publishing requires collaboration with internal and external stakeholders, including regulatory affairs, quality assurance, medical affairs, and clinical development teams. Our built-in submission project management and collaboration ensures that the regulatory submission is accurate, complete, and compliant.
Overall, Dossier/Technical File compilation and publishing is critical and our solutions help ensure save time/costs, cut cycle time and maintain compliance.
For PDF, some tools or plugins can help a bit but not fully. For Word, you have No easy options at all.
Several research articles and surveys point that the publishing Documents costs companies 20 to 40% of additional time. You can do the math based on how many documents you are publishing per month to see the Dollars spent on documents and Dossiers publishing. You can stop or minimize this $$ drain and free up time for your resources (and who wouldn’t love to get freed up from boring mundane manual tasks).
REGai Automates document publishing. Whether your source files are in WORD DOC or PDF, get submission ready files in SECONDS. With 300+ rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. You are in control as all this is done using a simpler user interface that’s cloud-based (or can be run as batch connecting to your EDMS or RIM systems).
ROI / Savings: 70% and above compared to your current costs. Guaranteed!
Functionality
1. Publishing Rules: Standard Out-of-box rules for FDA, EU, and other regions +you can use any custom publishing rules from our vast library on DOC or PDF (Tables, Font management, TOC, Bookmarks, Headers/Footers, Hyperlinks, File-level general options, and more)
2. File Format Options: Using data analytics to assess and prioritize regulatory risks, and to develop risk management strategies to mitigate these risks.
3. Mode: You can do Real-time or run as Batch (for large size files).
4. File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, BOX, and other 3rd party Sources.
5. Download: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources.
The use of regulatory analytics can help regulatory teams to make more informed and data-driven decisions, leading to more effective and efficient regulatory policies and compliance.
5. Access: Cloud (hosted on Private Cloud in USA/Germany)
- Pre-built country publishing Plans (over 70+ included)
- Custom Submission plans using our Template Management functionality
- Centralize all publishing activities
- Cross-country dossier linkages
- Different outputs (XML, Zip, Volumized PDF)
- Manage Life cycle easily
- Integrated with your current tools/systems