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 authorities 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: Regulatory operations publishing must comply with regulatory requirements, such as the International Council for Harmonisation (ICH) guidelines, regional regulations such as FDA regulations, and your internal rule books as well as standard operating procedures (SOPs).
- Collaboration: Regulatory operations 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, regulatory operations 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 $$ drain and free up time for your resources (and who wouldn’t love to get freed up from boring mundane manual tasks). REGai Automates document publishing. Whether your source files are in WORD DOC or PDF, get submission ready files in SECONDS. With 300+ rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. You are in control as all this is done using a simpler user interface that’s cloud-based (or can be run as batch connecting to your EDMS or RIM systems). ROI / Savings: 70% and above compared to your current costs. Guaranteed! 1. Publishing Rules: Standard Out-of-box rules for FDA, EU, and other regions +you can use any custom publishing rules from our vast library on DOC or PDF (Tables, Font management, TOC, Bookmarks, Headers/Footers, Hyperlinks, File-level general options, and more) 2. File Format Options: Using data analytics to assess and prioritize regulatory risks, and to develop risk management strategies to mitigate these risks. 3. Mode: You can do Real-time or run as Batch (for large size files). 4. File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, BOX, and other 3rd party Sources. 5. Download: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources. 5. Access: Cloud (hosted on Private Cloud in USA/Germany) In most companies QC is a Manual process. Whether you do in house, outsource or offshore, Manual QC is NOT acceptable when technology and options are available. Even if you outsource some of these, you are still spending time as part of “Oversight” that costs you time. Several research articles and surveys point that QC takes 10 to 30% of overall time in Document life cycle. Imagine if the author or a senior resource is doing this task, you can do the math based on how many documents are being QCed per month. You can stop or minimize this $$ drain and free up time for your resources to do more value add tasks. Not just $$, but Cycle time can be improved drastically for faster turn-around. REGai Automates QC. With 400+ QC checks built-in, you pick what QC to apply to which document. You are in control as all this is done using a simpler user interface that’s cloud-based. ROI / Savings: 50% and above compared to your current manual costs. Guaranteed! 1. Checks: Standard Out-of-box checks for FDA, EU, and other regions + you can use any custom checks from our vast library to comply/meet your Rule books and current QC checklists. Currently we have pre-defined packages for Clinical documents (like CSR), Labeling (USPI/SPC), and others. 2. QC + Fix: Opt to fix the way you want when an error is found while running QC checks. Saves lot of time instead of pushing back to authors or you opening documents and manually fixing. 3. File Options: File Options PDF, Word 4. Mode: Real-time or Batch (for large size files, tool can get directly push/pull from your current EDMS). 5. File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources. 6. Download: Along with Source and Output file (if you opt for fix), detailed QC report included which you can file for compliance purposes (no need of additional manual QC reports). 7. Access: Cloud (hosted on Private Cloud in USA/Germany) For high-volume projects, on-prem available. Functionality
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.Functionality