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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The Case for Tracking Regulatory Submissions
Dec15

The Case for Tracking Regulatory Submissions

The Submission Tracker assigns key dates to deliverables, for example, when a deliverable will be provided for publishing and when certain tasks related to that deliverable must be completed to in order to promote it to submission ready. The tracker is used to determine if submission content is being provided according to schedule and if publishers are completing tasks on time.

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Early Preparations for Your Establishment Registration SPL
Jul09

Early Preparations for Your Establishment Registration SPL

When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.

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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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