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

Navigating Electronic Submission Pathways

Specialized Software and Document-Preparation Services Can Streamline Process

  • 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.

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