Document Collection: Regulatory operations publishing functionality manages collection of documents from various teams (or external systems we can connect to). These documents can be 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 your 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: Regulatory operations publishing must comply with regulatory requirements, such as the International Council for Harmonization (ICH) guidelines, regional regulations such as FDA regulations, EU MDR and 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.

Pre-built country publishing Plans

Custom Submission plans using our Template Management functionality

Centralize all publishing activities

Cross-country dossier linkages

Different outputs (XML, Zip, PDF)

Manage Life cycle easily

Integrated with your current tools/systems