eCTD
eCTD is evolving to become the electronic submission format of choice in North America and Europe. As agencies move toward fuller acceptance of the eCTD format, industry is focused on transitioning their internal processes to support the eCTD.
Octagon's eCTD solutions provide:
- Expert eCTD consulting, guidance and customizable training
- Business process outsourcing for the entire submission lifecycle
- Integrated software solutions that propel eCTD processes forward while minimizing rework and maximizing quality
Our eCTD expertise is evident in our services and software products. In recent years, we have gained an in-depth understanding of the nuances of the eCTD submission format. We continue to offer solutions that help our clients address the challenges of generating and submitting quality and compliant submissions in the eCTD format.
Most of our competitors are focused on avoiding an RTF (refuse to file) from the agency. We have set the bar much higher. We want to provide the most reviewer-friendly, easily navigable and compliant eCTD submission. We do this through our cross-functional approach to developing documents and data for the submission and by taking advantage of experienced people, refined processes and state of the art technologies. Depending on the size of your organization, you may need assistance in multiple areas.
Our eCTD Offerings include:
eCTD Authoring Solutions
StartingPoint® — Submission Document Authoring Templates
eCTD JumpStart™ — Standards for storing and maintaining eCTD submission documents and data
Global eCTD Guidance Interpretation — Provides a common interpretation of agency guidances that can be used across global organizations and functional areas
eCTD Training — Embeds a common understanding of eCTD processes and deliverables
eCTD Submission Solutions
Submission Stewardship™ — Offers a virtual Regulatory Affairs and Operations staff to compile and submit original applications and maintenance submissions throughout the eCTD submission lifecycle
CDISC Conversion Services — Offer an outsourcing model for converting legacy data to CDISC compliant format for electronic submission.
ViewPoint eCTD Compiler — Automates compilation and lifecycle management of eCTD compliant output
Octagon's eCTD Viewer and Validator — Desktop applications that support viewing and validating of eCTD submissions across the lifecycle
ViewPoint eCTD Complete — Service and technology solution that provides complete, preconfigured eCTD functionality supporting compilation, viewing and validation of eCTD submissions
>> Click here to download our eCTD related offerings
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