Overview

Essenvia allows users to preview and publish a section or the entire project on-demand. Users can set account-wide publishing preferences that apply to any project created or override preferences for individual projects by setting project preferences.

Regulatory authorities such as FDA and Notified Bodies have provided mandatory technical requirements that need to be followed for the submissions. You can take advantage of preference features within Essenvia to set account and document-wide preferences.

Technical Requirements for regulatory documents:

A significant reason for slow review times for regulatory documents submitted to authorities is directly attributed to document format requirements. A quick summary of these requirements can be found below:

1. Language: All regulatory submissions are required to be submitted in English
2. Format and file size: The preferred document format is PDF. The maximum size of most files submitted can vary based on regulatory authorities -  for example, for FDA each file submitted cannot be more than 50MB but for Notified bodies it can be up to 500MB.
3. Optical Character Recognition, OCR, (searchable format): Non-searchable submissions are unacceptable and add to review times.
4. Bookmarks: Submissions should have bookmarks to aid in locating major sections of the submission document. Sometimes random bookmarks are created based on document headings and subheadings when converted to PDF format. These excessive, unnecessary, or confusing bookmarks auto-created in the PDF slow down review times.
5. Pagination: Each page of the submission should have a separate, sequential page number, starting with 1. It doesn’t matter how many pages or volumes are submitted – each page should have a unique number.
6. Signatures: Signatures are required for any signed document in the submission file. They can be digitally signed.

How can Essenvia help you eliminate additional review time and cost due to deficiencies in documentation requirements?

Essenvia was built for medical device submissions and has several capabilities that can eliminate the various reasons regulatory submissions can suffer delays. Nothing can be more painful for medical device companies than adding an additional 10 weeks to submission timelines. Essenvia's built-in features are infused throughout all the steps involved in creating a regulatory submission. The sections below explain safeguards and process improvements unique to Essenvia that dramatically improve your chances of meeting technical requirements every single time.

1. Initial preference setup
2. At the time of authoring
3. During publishing

Initial Preference setup

Essenvia allows preferences for document authoring and formatting at an account level.

1. Login to your Essenvia account as an Admin
   
2. Click on the profile icon on the top right corner and click "Go to admin"
   
3. Click on "PDF Preferences" in the Preferences section in the left-hand sidebar
   
   
4. Select your preferences for the table of contents, figures, pagination, front cover, headers, numbering, and table of content styles on this screen. 
   

At the time of authoring

Essenvia does not require users to number or format sections, sub-sections, or create bookmarks but the tool lays out best practices while creating a submission. If you would like to learn more about how to create a section, sub-section, text blocks, tables or to insert figures, check out the knowledge base article here. Since navigating a complex document and misplaced elements are the primary reasons why review times increase, Essenvia streamlines the process and takes the burden away from you while completing the submission.

We recommend considering the final submission and how each of the elements created will finally appear in the information hierarchy while working on the project.

During Publishing

With just one click, Essenvia can automatically create a PDF of the submissions that meets all the technical requirements mandated by regulatory authorities. Sections are numbered, Sub-sections are numbered, images and photos are captioned and all pages including the appendix are paginated. With Essenvia, it is easy to create a volume-based (combining sections together) submission or a non-volume-based single PDF submission.

Essenvia also automatically creates an active table of content and a bookmark of the sections, sub-sections, and appendices so the regulatory authorities can navigate and locate information easily, reducing review times. For advanced features we also allow users to have a table of tables and a table of figures added to the table of content.

Follow the steps below to learn more about how Essenvia builds and publishes a submission-ready document:

1. Login to your Essenvia account
   
2. Click on the Preview icon located next to Comment and Add User Icon on the top of the page
   
   
   
   
3. Choose your preferences on the screen including the following:
   
1. Section - you can choose specific sections or all sections
   
2. Section coversheets
   
3. Numbering preferences - you can choose to add numbering for sections, text boxes, figures, and tables
   
   
   
   
4. Click "Generate Preview"
   
5. The PDF will be created by Essenvia in the format required by the regulatory authorities. You can download the PDF and submit it to the regulatory authority.