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.

Read More
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.

Read More

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...

Read More

GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a submission for the first...

Read More

Simultaneous eCTD Submissions to Multiple Regions

Traditionally, a pharmaceutical company would seek to have a drug approved in one region, and then move to other regions around the world to seek approval. Typically, companies would seek approval in their country of origin, then pursue the biggest markets, and finally focus on the rest of the world. The advent of CTD provided a common organizational structure to create submissions around the world. The ability to reuse large parts of...

Read More