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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Improved eCTD Regulatory Resources Page

Many of you have probably benefited from the “eCTD Resource Page” in the past. For both previous and new users, there’s some good news – the site iRegulatory eCTD resource pages has been updated and expanded. The site features basic background, links to regulatory agencies, vendors and other eCTD resource pages, and a discussion forum for posting comments or questions. It’s a great opportunity for the...

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