Octagon's eCTD Consulting

Octagon's Process Consulting team has vast experience in electronic submission processes, document and submission lifecycle management and change control. Clients seek our consultants because of their unique combination of process and technology expertise. They understand the business as well as the standards and technologies that automate it. Octagon's consultants have been deployed to small and large organizations to develop and deliver transition strategies supporting document management, electronic submissions and eCTD.

Our Capabilities Assessments and Roadmaps provide a unique perspective on current organizational capabilities and documentation of the existence of or the need for standards. In addition, they provide a recommended approach that is time tested and proven to facilitate rapid transition to eCTD. Once the plan has been presented, Octagon consultants facilitate the implementation of the plan with project management, SOP development, tool training and process integration.We have helped numerous clients quickly transition to eCTD capabilities with minimal disruption and maximum efficiency.

In addition to consulting, Octagon also offers combined consulting and standards documentation packages such as eCTD JumpStart™. Octagon's eCTD JumpStart offering provides standards such as document naming conventions, bookmarking and hyperlinking standards and recommended folder structures to support eCTD submission document authoring.

Case Studies