Publishing & eCTD
Life sciences companies face a host of operational challenges with managing global regulatory affairs submissions. These include meeting complex timelines, fluctuation in submission volume throughout the year, variations in requirements from region to region, and the complexity of gathering data from different functions and from affiliates. In addition, companies must deal with the logistical challenges of managing IT tools and systems, many of which don’t provide an end-to-end view of the submission process.
Celegence: a Global Perspective to Submission Publishing
Celegence provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensure the provision of compliant and efficient regulatory publishing services. We can help streamline your end-to-end submissions management process, from dossier development to health authority interactions.
Our eCTD publishing services and document level publishing expertise take the complexity out of commonly experienced problems, such as formatting and hyperlinking issues, floating sections, and error corrections.
Celegence’s Dedicated Offerings Support
Dossier submission services to multiple health authorities
Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide
Regulatory intelligence services to interpret regional and national requirements for submissions
Comprehensive quality check and adherence to predefined SLAs
Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model
End to end services for Publishing, Submission and Archival of Dossiers for multiple regions
Management and Submission of IND Safety & Adverse Event Reports
Document Formatting and Publishing – Word Style Guides and PDF Navigation
If you’re curious how Celegence can help with your Publishing & eCTD
needs, reach out to us and one of our team members will get in touch with you.