Case study:
Expert and swift publishing support for an urgent EU Marketing Authorization Application
Background:
Boyds was approached by a biotech to manage the publishing of an EU Marketing Authorization Application (MAA) Submission for a new medicinal product in a very short turn around. The initial submission had previously been created by another team and needed significant modifications. The publishing team needed to clone the original New Drug Application (NDA) filing, address document issues, ensure the re-written content was properly integrated and re-linked within the electronic Common Technical Document (eCTD) Structure, and adjust and adhere to tight timelines whilst incorporating significant amendments.
Boyds approach
Our team had to clone the original NDA submission making sure that all regional specifications were followed, extracting content and re-writing content for each module. We had to re-align the project to meet the tight deadlines, which required meticulous planning to ensure that no content or metadata was lost or incorrectly transferred during the cloning process.
Several documents did not adhere to the required regional specifications, and in some cases outdated or inconsistent templates or formatting had been used. We needed to overhaul these documents ensuring they followed current guidelines and to ensure that the templates were fully compliant and consistent. Some elements for the submission had also been incorrectly located in the dossier requiring close review to ensure these were fully aligned with the electronic Common Technical Document (eCTD) structure and correctly referenced in the submission documents.
A significant portion of the content had to be re-written based on new scientific data and updated regulatory requirements. This created additional challenges ensuring that all links, cross-references were updated and correctly linked to their respective sections. Given the volume of content, this process was critical to avoid submission delays.
Impact and Outcomes
By offering a full end-to-end end service in house, Boyds was able to leverage the close rapport between content authors, project managers and publishers. Regular meetings with the client ensured that any discrepancies or delays were quickly identified and resolved. By fostering a positive, proactive approach the Boyds team managed to keep the project moving forward, even under tight deadlines, and our dedicated Quality Control team ensured any inconsistencies were flagged early allowing time for revisions.
Despite the significant challenges, our streamlined approach allowed us to successfully turn around the project, giving the client peace of mind that deadlines would be met, and that the submission was of the highest quality. The revised MAA submission, now eCTD compliant was completed within the new timeline, with no validation issues.
