Expert Regulatory Publishing Support During Workload Peaks

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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 manage the overflow in order to meet the organizational deadlines. One option the manager may consider is partial eCTD outsourcing during submission workload peaks.

Partial eCTD outsourcing, also known as a hybrid approach, is an alternative to full outsourcing in that it allows for internal staff to maintain hands-on publishing responsibilities and delegate some of the eCTD preparation work to a trusted service provider. Utilizing a service provider reduces the overhead for the regulatory operations manager and his/her organization in that it is not necessarily a requirement to provide additional resources with hardware and software to publish. The additional publishers may be added to the project on an as needed basis and work remotely to get through the workload peak.

Productive hybrid eCTD compilation is best executed through good planning and frequent communication. Clear delegation of responsibilities and publishing standards is important to ensure consistency and quality while building the eCTD submission. Standing team meetings to discuss status and issues are important as well to ensure good communication and task management throughout the duration of the project.

Once the project is complete and the workload peak subsides, business as usual returns to the regulatory operations team. Working together on an as-needed basis, the trusted service provider may be called upon again in the future should the need rise again for additional support.

Author: Emily Onkka

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