StartingPoint® Case Studies
Client Engagement:
StartingPoint®, Process Consulting, Submission Stewardship Program™
Scenario:
An emerging biotechnology company acquired a drug to enhance their product portfolio. The original IND for the product was previously submitted in eCTD format. Once the product was acquired, the client was responsible for continuing maintenance of the IND submission in eCTD format even though they did not have eCTD processes or tools in place. The client purchased StartingPoint® and started using the relevant IND templates immediately to support their regulatory obligations. Additionally, Octagon's Process Consultants facilitated the rapid implementation of eSubmission-ready standards, including document naming conventions, a standardized folder structure for storage and access to the documents, and standardized document processes. This client also engaged Octagon's Regulatory department to support on-going maintenance activities for their eCTD submission through the Submission Stewardship Program™.
Value Statement: Octagon's eCTD standards, processes and technologies, combined with our well-known submission outsourcing strategies, enable the client to meet their regulatory obligations in a timely fashion.
Submission Outsourcing and Submission Stewardship
Octagon began working with a small pharmaceutical company to compile and publish their first eCTD submission for an original application. The company was a virtual company with only one regulatory person. Because they had no existing eCTD capabilities, Octagon worked with the client to complete the original application and subsequently took over maintenance of the submission through the Submission Stewardship program.
Submission Stewardship in Multiple Formats for US and Europe
Octagon worked with a global client to provide support for their US and European submissions. Though the client had extensive knowledge of paper submissions, they had no internal expertise with electronic submissions in the eCTD format in the US or Europe. Octagon's Regulatory Affairs team provided guidance on submission strategy for two US applications. Through the Submission Stewardship Program, Octagon also provided support for maintenance submissions for these applications (one eCTD and one hybrid). Octagon's combined Regulatory Affairs and Operations teams also completed the compilation, publishing and quality checking of an original eCTD application through the decentralized procedure in Europe. The team continued to maintain the European submission under a Submission Stewardship agreement.
