Publishing teams spend hours formatting documents, generating PDF documents, performing quality checks, compiling documents and troubleshooting issues to ensure they can deliver agency-compliant submissions on time.
These stringent timelines typically range from seven (7) days for CTA/ANDAs to three (3) months for larger submissions, BLAs and NDAs.
Publishing activities are time-consuming and include many repetitive tasks that are prone to human error. This is one of the reasons the industry is experiencing considerable resource burn-out in the publishing & submission space, with most of the submissions completed in the last minute, ‘25th-hour rush’.
current landscape & challenges
publishing automation – innovation
Building on a vast experience from executing more than 100,000+ global submissions – including eCTD, NeeS and Paper formats – for large and small-to-medium BioPharma companies, Freyr has developed the industry’s first publishing automation innovation tool-kit. Built from a ‘ground-up’ approach of evaluating day-to-day publishing activities from a simplified, fresh perspective, Freyr’s Digital Publishing Automation is built using an array of RPA & NLP modules that automate:
- Document-level publishing automation
- Submission-level publishing automation
Many manual-intensive, repetitive and contextual document processes have been automated including PDF document properties, PDF page properties, bookmarks, and hyperlink creation/properties, document assignment to eCTD folder sections, and more. At the submission-level, we have built 'bots' to assign files in the correct eCTD sections, adding the correct external hyperlinks as well as the whole process of compilation validation and finalizing.
realized, real-world, exponential benefits through automation
an NDA submission that used to take 90 days can now be submitted in 30 days
