How to attach the Regulatory Bundle document?

To attach the Regulatory Bundle document to a submission, follow these steps:

Prepare the Regulatory Bundle: The Regulatory Bundle is a collection of documents that are required to be submitted to regulatory agencies for approval of a medical device or pharmaceutical product. It typically includes documents such as the product labeling, instructions for use, clinical study reports, and other regulatory submissions. Ensure that all the necessary documents are compiled and organized in a logical and clear manner.
Save the Regulatory Bundle as a single file: To make it easier to attach the Regulatory Bundle to a submission, save all the documents as a single file. You can do this by creating a ZIP or PDF file that contains all the documents. Make sure that the file size is within the submission system's limit.
Log in to the submission system: Access the submission system where you will be submitting your Regulatory Bundle. This could be an electronic submission system provided by the regulatory agency or a submission management system provided by your organization.
Create a new submission: If you haven't already, create a new submission in the system. Provide the necessary information such as the product name, submission type, and contact information.
Attach the Regulatory Bundle: Once you have created a new submission, you will be prompted to attach the Regulatory Bundle. Click on the "Attach File" or "Browse" button to locate the single file that you saved earlier. Select the file and click "Open" or "Attach" to upload it to the submission.
Verify the attachment: After the file has been uploaded, verify that it has been attached correctly. Check the submission preview or confirmation page to ensure that the Regulatory Bundle file name and size are displayed correctly.
Submit the submission: Once you have attached the Regulatory Bundle, review the submission to ensure that all the necessary information has been provided. When you are ready, submit the submission to the regulatory agency for review.
Follow up on the submission: After the submission has been submitted, follow up with the regulatory agency to ensure that they have received and are reviewing the Regulatory Bundle. Provide any additional information or clarification as needed.