Implementing a Cloud-based eCTD Solution
Apr25

Implementing a Cloud-based eCTD Solution

Cloud technology considerations should not be restricted to your organization’s IT professionals any longer. Business owners must take an active role in understanding the technology and its potential impact. Deliberations on adoption of an in-house system deployment versus cloud-managed systems center on initial implementation and ongoing maintenance. Additional points to weigh include resource support and the value of your...

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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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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...

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Hybrid Software and Services Model for eCTD Submissions

Regulatory Publishing is unfortunately not an exact science. Many different factors from different facets of an organization come into play as you prepare your applications for submission. Coordination is a must in organizing and managing the process from start to finish. Using templates to ensure content is written in the proper format, rendering into acceptable PDF documents, compiling them into the appropriate table of contents,...

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eCTD and Document Management Cloud Solutions
Oct24

eCTD and Document Management Cloud Solutions

With increasing options for cloud-based eCTD and electronic document management systems (EDMS), small and large pharma companies are faced with evaluating the benefits and risks of implementing these systems in the cloud compared to traditional onsite or hosted deployment models. Cloud eDMS Benefits One benefit is streamlining the implementation effort. A cloud-based EDMS should be up and running within weeks compared to an onsite...

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