eCTD Case Studies

Client Engagement:
Electronic Submission Assessment, Global eCTD Guidance Interpretation

Scenario: A growing pharmaceutical company had implemented some templates and standards to support electronic submissions. They requested Octagon's expertise in developing an assessment of their capabilities to support global eCTD submissions. Octagon teamed with the client to conduct a thorough, cross-functional assessment of their capabilities. As a result of the assessment, it was determined that the client was in need of a common, organizational understanding and interpretation of global eCTD guidances. The client chose to purchase Octagon's Global eCTD Guidance Interpretation to provide an immediate, single-source interpretation of US and EU electronic submission guidances. The purchase alleviated the need for internal resources to compile, document, review and gain consensus on interpretation, which would have been a significant undertaking and a resource-intensive project, potentially delaying their implementation of eCTD submissions.

Value Statement: Octagon provided a packaged solution that addressed the client need to move quickly and implement eCTD globally. The client realized time and resource savings which simultaneously resulted in a quicker transition.