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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Globalization, Resource Constraints Top List of Regulatory Operations Concerns

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: What are your biggest challenges – what keeps you up at night? Although we received four different answers from the panelists, they all had a...

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