The Agile Methodology and Regulatory Publishing
Sep24

The Agile Methodology and Regulatory Publishing

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

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How We Moved to Agile for Regulatory Submissions and Why It Works
Sep10

How We Moved to Agile for Regulatory Submissions and Why It Works

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

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How Technology is Streamlining Regulatory Publishing
Apr16

How Technology is Streamlining Regulatory Publishing

Submission publishers face a number of challenges as they perform the day-to-day tasks associated with compiling and inspecting the quality of an eCTD. Innovations in technology are easing the burden in terms of actions publishers must perform manually. Streamlining publishing tasks saves time, effort, resources and in the end, produces a higher-quality submission. Susceptibility to error is a corollary to the number of labor-intensive, manual actions performed by your publishing team. Manual processes also extend the publishing time frame, induce extra effort and require greater resources for quality assurance.

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Hyperlinking Impact on the Critical Path to eCTD Submission Deadline

This is Part 2 of a larger article on hyperlinking best practices. To read Part 1, Hyperlinking: Making the Most of Navigation in eCTD Submissions, click here.  Regulatory operations is frequently asked about submission turnaround time once the final document is delivered. The strategies around how documents are authored will often have an impact on accurately answering this question. When authors are writing submission documents and...

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Expert Regulatory Publishing Support During Workload Peaks

There are many companies that have highly effective, small teams of regulatory operations publishers that generate eCTD submissions in-house. These small teams of publishers manage existing eCTD applications through preparing routine maintenance submissions, supplements, and small original applications with ease. However, when the workload exceeds the production capacity, the publishing manager is faced with a decision of how to...

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Converting a Paper IND to eCTD Format
Jan22

Converting a Paper IND to eCTD Format

Conversion of a paper IND to eCTD format can be done at any time the sponsor is ready to implement eCTD. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to the application as an eCTD will contain the appropriate form (1571 or 356h) and cover letter indicating that all future submissions...

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