Looking for a Global Dossier Publishing & Submissions Partner?
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.
Your goal: Efficient Global Publishing & Submissions
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.
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.
Who We Have Helped with Publishing:
Manage eCTD and NeeS Worldwide
Global Submissions
Dossier submission services to multiple health authorities.
Seamless Format Conversions
Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide.
Expert Regulatory Insights
Regulatory intelligence services to interpret regional and national requirements for submissions.
Quality Assurance
Comprehensive quality check and adherence to predefined SLAs.
Integrated BPaaS Support
Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model.
Complete Dossier Services
End to end services for Publishing, Submission and Archival of Dossiers for multiple regions.
IND Safety Management
Management and Submission of IND Safety & Adverse Event Reports.
Document Formatting
Document Formatting and Publishing – Word Style Guides and PDF Navigation.
3 Ways We Make you More Successful
Faster Turnaround Times
First-time Right Submissions
Submit to Multiple Countries Easily
What our Process Looks Like
Our professional eCTD services encompass initial consultation, meticulous document preparation, precise eCTD publishing, rigorous quality assurance, and comprehensive submission tracking. We ensure efficiency, accuracy, and compliance at every step, providing peace of mind and streamlined submissions.
Initial Consultation
Our initial consultation for publishing services ensures a clear understanding of your regulatory needs. We tailor our approach to streamline your submission process, saving you time and reducing costs.
Document Preparation
Document preparation is meticulous and tailored to meet regulatory standards. We ensure every detail is accurate, streamlining your submission process and enhancing compliance.
eCTD Publishing
Our eCTD publishing service guarantees that your submissions are formatted precisely to regulatory requirements. We ensure seamless electronic submissions, enhancing efficiency and compliance.
Quality Assurance
Our quality assurance process is thorough and rigorous, ensuring that every submission meets the highest standards. We identify and correct issues proactively, guaranteeing compliance and accuracy.
Submission & Tracking
With our submission tracking service, you stay informed every step of the way. We provide real-time updates and detailed reports, ensuring full transparency and peace of mind throughout the submission process.
What Our Pharmaceutical Clients Are Saying
“Celegence’s expert publishing team allowed us to submit our briefing book and other documents to the US FDA in eCTD format, thereby reducing dependencies on our core team and allowing them to focus on more strategic initiatives.”
“I am incredibly satisfied with the work Celegence has done thus far. They communicate well and receive feedback well. I find the team I have been assigned incredibly easy to work with, friendly, and people I genuinely look forward to speaking with once a week.”
“Celegence’s team serves as an extension of our internal publishing and compliance team and has allowed us to achieve significant time and cost savings in comparison to our previous regulatory partners.”
Maximize the Efficiency of your Publishing Team with Celegence
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