The Latest on FDA Tobacco Submissions
Aug08

The Latest on FDA Tobacco Submissions

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) and the tobacco industry are in the exploratory stages of developing a standard for electronic submissions. Statistics on tobacco product applications evaluated to date combined with the scant regulatory experience of the industry indicate that progress toward a standardized submission and review process will be deliberate.

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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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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...

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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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eCTD Tips & Tricks, Part III

Hey Everyone. It has been a few months since my last entry. I trust your holidays were enjoyable. Hopefully you didn’t think about work too much. That’s what this final chapter is going to focus on, actually – not thinking about work. In the previous installments, I talked to you about the tools and teams to help you make regulatory submissions easy. But since I’m going to assume that since I left you alone there for a few...

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