Publishing

Publishing & eCTD Services - Life Science Regulations US

Publishing & eCTD
Services:
Tackling Global
Submission

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.

Publishing eCTD Dossiers - Life Science Regulations - Celegence

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

Contact Us

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.

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