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Streamlining Regulatory eCTD Publishing

Automated eCTD submissions can save companies time, money.

By Scott Mackey

January 20, 2009 | When it comes to document and information management, nowhere are stakes higher than in the pharmaceutical industry. A day’s delay can mean the loss of millions of dollars and, more importantly, unnecessary postponements in getting a product approved.

To accelerate and standardize the review process, the industry has been moving from antiquated paper-based submissions to an entirely electronic system, leveraging XML and PDF technologies. In fact, as of January 2008 the FDA mandates that all submissions are done using eCTD (electronic common technical documents), an XML-based structure containing high-quality PDF documents. Other global regulatory agencies have also recognized the efficiencies of an electronic submission process. And even though paper submissions are still accepted in other international jurisdictions, thousands of submissions have now been made electronically and the percentage of companies still using paper is dropping rapidly.

While the FDA introduced the eCTD standard to simplify and accelerate the submission process, organizations still struggle to automatically and accurately convert submission documents from various formats into submission-ready PDFs. Key documentation is often compiled and maintained on a series of unmanaged Microsoft Word documents and even hand-written forms. The flood of documents that flows through the submission process often lacks conformance to any common standard. To ensure the rapid and successful review of a submission, these documents must go through an extensive manual Quality Assurance process to ensure they have the correct bookmark structures, fonts are properly embedded, hyperlink styles meet FDA guidelines, cross-references are applied, and all links are verified. This process can delay a submission by weeks or months, eroding the time before a patent expires and directly impacting the bottom line.

Building Submissions

The key to managing this tedious submission process is to ensure that the document conversion and publishing technologies used in building the submission can accurately and seamlessly present a high volume of information from multiple sources and create documentation suitable for the final submission.

Robust PDF rendering is the backbone of many document management workflows and essential for the eCTD submission lifecycle. Improving renditions reduces quality assurance churn to only minutes per document (searching for missing or broken hyperlinks usually takes hours to complete). Manual document review and editing can typically take two hours per document; automating document transformation and generating submission-ready documents initially can reduce this time to ten minutes. For a company that submits just 100 documents per week, automating the process can save 183 man-hours per week or $572,000 per year (based on a salary of $60 per hour). The cost savings, projected over submissions running into the hundreds of thousands or even millions of pages, have proven to be enormous.

Submission-ready PDFs are flexible and contain an almost limitless set of features, including elements like access control, standardized hyperlink styles, embedded fonts, comprehensive tables of contents, and bookmark structures. These PDF documents are also scalable throughout the submission lifecycle, particularly important given the FDA’s increasingly assertive use of post-marketing “risk minimization action plans” (RiskMAPs).

Here are a few key steps that organizations should keep in mind when compiling documents for eCTD submissions:

Document rendering—The better the quality, the less time required to review and update each document.

Ease of Integration—Choose an application that employs stable, open protocols and standards (XML, Web services), which can fit into the infrastructure.

•             Natural Workflow—The technology needs to fit seamlessly into the overall document workflow of the organization. Eliminate steep learning curves and the rate of adoption will soar.

•             Compliance Ready—Ensure that the application has a successful history in life sciences/regulatory submissions. 

Document Transformation—Applications should be able to handle all document transformation needs, including document assembly, OCR text recognition, and document conversion.

Scalability and Reliability—It’s important to have a robust application that can scale to meet fluctuations in volumes coupled with the critical nature of speed to market.

A robust regulatory publishing infrastructure is designed to be a foundation for growth for life sciences organizations. This critical infrastructure component takes advantage of existing investments in skills and technology to achieve document management efficiencies that support the critical work being conducted on behalf of the population—and corporate shareholders. The right eCTD technologies can result in significant cost-savings, rapid ROI, and faster time to market. 

Scott Mackey is the director of product management for Adlib Software. He can be reached at

This article also appeared in the Jan-Feb 2009 issue of Bio-IT World Magazine.
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