Creating FDA-Compliant PDF Submissions

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FDA PDF Requirements

The FDA specifies strict requirements for PDF documents submitted through its electronic submission gateways. These requirements ensure that documents are readable, searchable, and navigable by reviewers. The key requirements from the FDA's Portable Document Format (PDF) Specifications are:

• Text searchability: All PDFs must be fully text-searchable. Scanned images of text are not acceptable without OCR conversion.
• Navigation: Documents must include a hypertext-linked Table of Contents and bookmarks that reflect the document structure.
• Font embedding: All non-standard fonts must be embedded in the file.
• No security restrictions: PDFs must not have security settings, password protection, or restrictions on printing or copying.
• Initial view settings: Documents must be configured to open with the bookmarks panel and the first page visible.

Step 1: Prepare the Document in Adobe Acrobat

Before adding bookmarks and a TOC, use Adobe Acrobat to verify and correct the base document:

Ensure Text Searchability

If your document was created from scanned pages, use Acrobat's OCR feature (Tools > Scan & OCR > Recognise Text) to convert the image-based pages to searchable text. After processing, perform text searches to verify that all content is searchable.

Embed Fonts

Go to File > Properties > Fonts to review the font list. Any font shown as not embedded must be embedded before submission. In most cases, re-saving through the PDF printer or using Print to PDF from the source application will embed all fonts. The Acrobat Preflight tool can also identify and fix font embedding issues.

Set the Initial View

Go to File > Properties > Initial View. Set Navigation tab to "Bookmarks Panel and Page" and confirm the page layout and magnification are appropriate for your submission.

Verify Security Settings

Go to File > Properties > Security and confirm that no security method is applied. If a password or restrictions are present, remove them before submission.

Step 2: Create Bookmarks with Mapsoft Bookmarker

FDA submissions require structured bookmarks that reflect the document hierarchy. Mapsoft Bookmarker automates the creation of these bookmarks from the document's heading structure, eliminating the need to create them manually page by page.

Generating Bookmarks

Open your PDF in Adobe Acrobat and launch Bookmarker from the Mapsoft menu. Configure it to identify headings from font attributes, paragraph styles, or text patterns in the document. Bookmarker will generate a hierarchical bookmark tree that mirrors the document's section structure.

Organising the Bookmark Hierarchy

Review the generated bookmarks in Acrobat's Bookmarks panel. Ensure that main sections are at the top level and subsections are correctly nested beneath them. A well-organised hierarchy is essential for producing a clear TOC in the next step and for enabling reviewers to navigate the document efficiently.

Step 3: Generate the Table of Contents with Mapsoft TOCBuilder

Once the bookmarks are in place, Mapsoft TOCBuilder generates a formatted, hyperlinked Table of Contents based on those bookmarks.

Configuring TOCBuilder

Open TOCBuilder from the Mapsoft submenu. Configure:

• Levels: Map each bookmark level to a TOC level with its own font, size, colour, and indentation.
• Leader lines: Add dot leaders between the entry text and the page number for a professional, readable layout.
• Hyperlinks: TOCBuilder automatically links each TOC entry to its corresponding page in the document.

Inserting the TOC

TOCBuilder inserts the generated TOC pages into the document at the specified position. After insertion, verify that all links work correctly by clicking entries in the TOC and confirming navigation.

Compliance Checklist

Before submitting, verify each of the following:

• All text in the document is searchable (test with Ctrl+F)
• All non-standard fonts are embedded (File > Properties > Fonts)
• No security settings are applied (File > Properties > Security)
• Bookmarks are present and correctly structured
• A hyperlinked TOC is present at the beginning of the document
• The document opens with the bookmarks panel visible
• All internal links and TOC entries navigate to the correct destinations

Automating FDA Compliance Workflows

For organisations that produce large volumes of FDA submission documents, manual preparation quickly becomes a bottleneck. Mapsoft can develop custom automation solutions that batch-process documents through the preparation pipeline — applying OCR, generating bookmarks, inserting TOCs, and verifying compliance — across an entire submission package. Contact us to discuss your workflow requirements.