How do I make sure my FDA submissions are compliant?

Life science companies are on a mission to bring life-saving medicines and products to market as quickly and safely as possible. Yet, doing so requires jumping through necessary regulatory hoops. Without immediate access to intelligent data, making sure FDA submissions are compliant will be more complicated than necessary.

Daunting Data Capture

One of the most challenging aspects of preparing data for FDA consideration is capturing the thousands of documents that are required for submissions. The information may come from dozens of internal and external sources and in hundreds of different formats. If FDA submission materials are incomplete or incorrect it may significantly delay approval processes.

The Role of Searchability

To meet regulatory expectations, pharmaceutical companies must be able to find what is expected. However, a significant portion of pharmaceutical data is unstructured, which means it isn’t searchable. The application of high-accuracy OCR to anything that is non-searchable is a highly effective way to create documents that can be easily found, shared, and organized. It is easier to surface relevant information when documents are grouped by type, indexed, and metadata-tagged. Ultimately, searchable documents are an integral part of a high-quality submission that reviewers at the FDA or EMEA (Europe) can easily navigate.

FDA Requirements

Proper Formatting Matters

The FDA, and other regulatory agencies, also have specific PDF guidelines that dictate structure, how documents are formatted, their size, and how they are packaged. Automation technology developed for Life Sciences' unique needs enables companies to assemble and format hyperlinks and bookmarks, with navigation-rich content, resulting in submission-ready PDFs for FDA approval. The high quality means that new life-saving drugs and devices get to market faster than ever.

Technical Considerations

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) require that submitted documentation meets their electronic common technical document (eCTD) format. In addition, the software used to create the regulatory submissions need to follow 21 CFR 11. While these requirements may seem stringent, the goal is to ensure that Life Sciences organizations have control over their data, including who enters it and who modifies it. The FDA also wants to ensure that the appropriate people can quickly and accurately access the data. Overall, there needs to be controlled processes for generating this data. The technology used is mission-critical and typically part of a strictly validated environment where everything is documented.

Land Submissions the First Time With Adlib

PDFs generated using the Adlib document transformation platform meet both the technical requirements for PDF submission and are compliant with the FDA and EU requirements for the use of electronic systems. Adlib offers an enterprise-grade rendering solution that meets and exceeds the requirements for compliant FDA submission, including:

• Centrally managed, high-quality document-to-PDF conversion
• Accurate Optical Character Recognition (OCR) for non-searchable documents
• Technical criteria Validator helps eliminate FDA rejections based on document technical criteria
• Proven scalability, and load balancing for mission-critical, zero downtime processes
• Integration with Documentum, OpenText, and other ECM systems, as well as business tools like Dassault ENOVIA PLM and K2 Blackpearl
• An intelligent Rules Engine for metadata-driven process automation
• Application of digital signatures and PDF security
• A reliable and highly available architecture
• A simple web-based management console

The Adlib platform‘s 20+ year track record has enabled pharma companies to automatically convert regulatory-compliant documents at scale into searchable, standardized PDF formats to navigate FDA submissions with confidence, accuracy, and ease.

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