eCTD Services for an emerging biotechnology company with an exciting new product to take to market having no internal capacity for the preparation of the licensing submission.
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Projects
Outsourced eSubmission preparation
Planning and implementing eCTD capability
A mid-tier pharmaceutical company with established European business is planning submissions to European and US authorities in the next two years.
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Running an eCTD Awareness Programme
A mid tier pharmaceutical client is about to implement an electronic Document Management System (eDMS).
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Preparing and Measuring an eCTD Pilot Submission
A pharmaceutical company has many years experience of paper submissions. It plans to implement authoring templates and prepare a business case for investment in a publishing tool.
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