10 Small Submissions
No more than 10 Documents per submission
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
