March 15, 2010 (Vol. 30, No. 6)

Specialized Software and Document-Preparation Services Can Streamline Process

An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents come from peer-reviewed scholarly literature.

Obtaining, assembling, transmitting, and managing this volume of materials— before and after any initial submission—is a major task for any pharmaceutical or biotech company. This is true regardless of whether an electronic submission is submitted to a regulatory agency or if traditional paper documents are submitted in those countries where the option still exists. Regulatory affairs professionals who have submission experience know firsthand how time consuming, expensive, and downright exhausting it can be.

In 2008, the FDA mandated that all electronic submissions adhere to the electronic common technical document (eCTD) format. The eCTD standard poses distinct challenges as scientific literature is not typically published in this format but needs to be reformatted to fit the FDA standard.

Even though it has been two years since the electronic system was implemented, many pharmaceutical companies are still struggling to navigate the approval process effectively. Help is available though. Acquiring the necessary published literature for the regulatory approval process can be standardized and facilitated by a CRO, specialized software supplier, or a document-preparation service.

Peter Derycz

eCTD Format

The eCTD format was designed by the International Conference on Harmonization, it represents a common organization structure for the submission of regulatory information to worldwide health authorities such as the FDA.

An eCTD document is composed of five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports, and Clinical Study Reports. The reason this format was chosen is because it is optimized for copying/pasting, viewing/printing, annotating, facilitating the export of information to databases, searching within and across applications, and navigating through the document.

As with all electronic submissions, delays can arise when last-minute requests for FDA-quality documents are made. It is no longer acceptable to have documents with anything but clean text. Making sure these documents are acceptable can be a complex process that involves a number of parties. Currently, workflow at many companies is decentralized with multiple insourcing and outsourcing providers.

A pharmaceutical company’s information center might bear responsibility for the task of removing any stray marks, while regulatory affairs professionals might ensure that the documents are formatted, modified, and assembled in a manner consistent with a regulatory agency’s specifications. It involves a great deal of management and juggling before, during, and after any submissions are made.

Companies need a centralized workflow system with standards in place. The eCTD format requires enhanced and specific digital document formatting and the inclusion of key navigation aids, making last-minute requests even more problematic and delaying the drug approval process even further.

When the authorities reading a submittal encounter noncompliant PDF files, they can stop the review until the pharmaceutical or biotech company supplies them with corrected versions—a seemingly finite detail that can cost companies huge sums in lost revenue by impacting time to market and stock prices. As the adage goes, time is money, and this is particularly applicable when it comes to getting a drug through the regulatory approval process and successfully to market.

Electronic submissions to FDA have become a daunting task for many biotech and pharmaceutical companies.

Document Services

There are services dedicated specifically to helping companies whose expertise lies in drug development to avoid the pitfalls and hold-ups associated with the approval process. For example, CROs offer clients a wide range of outsourced pharmaceutical research services including document preparation.

There are organizations that employ regulatory experts whose familiarity with the eCTD format can facilitate the compilation of INDs and NDAs. These experts include former government officials and specialists who possess broad experience and insight regarding all stages of FDA submission, and who have mastered the details of eCTD.

A second option involves the use of specialized software that can facilitate compliance with eCTD format requirements. The features of web-based software are preconfigured to comply with various regulatory standards, including eCTD. Specialized software allows users to write, compile, review, quality-control, publish, and transmit eCTDs.

Additionally, the software provides the status of documents at different phases of the submission process with appropriate icons, alerts, and notifications. Users can work on the same submission and get access to information in real time about the status of all submissions. A built-in intelligent validation engine proactively monitors user actions and prevents operations that may lead to potential errors downstream. 

There is also a third option, one that can be used to complement the first two options: A document-repurposing company can help manage the article-preparation process. A dedicated eCTD document service can provide valuable aid to companies facing the challenges of regulatory submissions, as well as help their CRO and software suppliers.

Such a service is capable of processing orders for documents either singly or in batches and procuring them according to a standard service-level agreement. It can ensure that the retrieved documents are digitally formatted to internal and local regulatory specifications and will oversee quality control and assurance processing. The service can also be set up to report on the details of usage for every document requested by the company.

One of the most striking differences between this arrangement and the traditional submission process involves the timing of document preparation. Traditionally, when paper versions of documents were used, the preparation was undertaken immediately prior to submission. With electronic submission, documents can be prepared continuously from the start of clinical trials, potentially saving considerable time and money later on. 

An independent service will not only have specialized expertise in managing information and electronic resources, but will also have a thorough familiarity with both the eCTD format and current copyright laws.

One way to speed your company’s path  through the regulatory approval process is to have your regulatory affairs personnel, submissions consultants, and CRO consider utilizing specialized software and a document-repurposing company to find a solution that will benefit your company and ultimately the people who will reap the benefits of your drug.

Peter Derycz ([email protected]) is chairman and CEO of Derycz Scientific. Web:

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