Regulatory operations publishing involves the compilation, preparation, and submission of regulatory documents to health authorities or notified bodies to support the approval and maintenance of products. Our solution supports following regulatory operations publishing areas:
- Document Collection: Regulatory operations 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.
- 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 and our tool will handle all these steps as part of document automation process to save you time.
- Document Publishing: The prepared documents are then converted into a submission-ready format (using our built-in “submission ready” functionality), and compiled into a submission package. This package is then published to the appropriate regulatory authority’s expectations.
- Submission Tracking: Regulatory operations 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.
- 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.
- Compliance: Submission Tracking: Regulatory operations 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.
- Collaboration: Submission Tracking: Regulatory operations 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.
1. Identify the Submission Type: The first step in regulatory submission planning is to identify the type of submission required, such as a new product or amendment or variation. With right templates and TOC, our solution will help determine the specific requirements for the submission package.
2. Develop the Submission Plan: Once the submission type has been identified, a submission plan is shown in the tool. This plan includes timelines, responsibilities, and milestones for the submission.
3. Identify Required Documents: The submission plan also identifies the required documents for the submission package
4. Compile and Prepare Documents: Once the required documents have been identified (and in some cases auto compiled by the tool), they should be prepared for submission. This includes formatting, editing, and review to ensure accuracy and completeness and our solution will automate all these steps.
5. Submit the Package: Once the submission package has been validated, it can be submitted to the health authority electronically using our Gateway (or configure yours). The submission should be tracked to ensure timely receipt and review.
6. Manage Post-Submission Activities: After the submission has been made, there may be additional requirements or follow-up activities, such as labeling updates or manufacturing changes. These activities are tracked and managed by our tool to ensure compliance with regulatory requirements.
Overall, regulatory submission planning and tracking is a critical function as it ensures compliance with regulatory requirements and facilitates the approval of products. Using our solution, Effective planning and tracking of submissions can be performed to ensure timely approval and bring products to market faster.
Publishing is Pain. Doesn’t matter what tools you use, which vendor you outsource to or how good your trainings/instructions may be to those who produce/author source documents.
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!
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).
File Format Options: PDF, Word, XML, Zip multiple files in one go as well.
Mode: You can do Real-time or run as Batch (for large size files).
File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, BOX, and other 3rd party Sources.
Download: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources.
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
- Automate validation based on your checklists
- Create custom validation plans at dossier level and different plans for the documents within those dossiers (Standard and Custom dossiers)
- Inter-Document hyperlinks check and automate updates
- Auto-update of File Names, Elements, Leaf titles matching to your internal standards
- Selectively test validation paths of the defined checks and parameters