Regulatory Publishing and Submissions
End-to-end technology-powered eCTD submissions
End-To-End Publishing & Submission Services
With over 2500 submissions to different regulatory authorities across the globe, Celegence has well-established processes that outline every detail related to the prerequisite of the eCTD submission, with multi-level QC to ensure 100% accuracy at each step.
Our team has experience with all types of regulatory submissions including IND, ANDA, NDA, and BLA dossiers. Our teams work in different geographies and time zones in US, Europe, and Asia to ensure real-time support and coordination across the globe, ensuring 100% resource availability to our clients.
Electronic Submission Services
Word Formatting
Document Level Publishing
Submission-Level Publishing
Hans van Bruggen
Chief Scientific Officer
Received DIA awards for contributions to DIA Europe and DIA RSIDM.
Implemented software to reduce regulatory impact assessments from weeks to minutes.
Koen Janssen
Compliance Manager & Regulatory Operations Associate
Development and customization of tools that help regulatory teams save time and reduce costs.
Maikel Bouman
Director of Regulatory Operations & Publishing
Successfully submitted the initial application sequence for a full NDA to the FDA in just 12 days, publishing 645 PDFs and 450 dataset files—an effort that typically takes months.
Supported FDA approval of the first gene therapy for children with Metachromatic Leukodystrophy by submitting 65 sequences in 11 months.
Pradeep Gangavaram
Director – Regulatory Services
Led several RIM/eDMS and publishing system migrations.
Successfully managed xEVMPD integration for a global healthcare business unit.
Naga Somu
Regulatory Affairs Specialist
Delivered 77 advertising and promotional projects for multiple product launches in a single day.
Received the Celegence President’s award in 2022.
Cloud eCTD viewer and dossier management for electronic publishing and submissions
Our proprietary cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers. It allows you to share, view, and review eCTD, NeeS, and other dossier formats from any region and access them in any location.
The hybrid solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud.
Features of Dossplorer™ eCTD Viewer:
Intuitive MS Word templates for eCTD-ready documents without software installation
Dosscriber™ helps stand-alone regulatory documents for, amongst others, NDA/BLA, IND, NDS, MAA, CTA, PIP, scientific advice, and briefing packages.
With consistent document structure, naming, and eCTD-readiness, Dosscriber™ templates facilitate repurposing documents across countries, products, and dossier types – without rework.
Features of eCTD Document Templates:
Your Trusted Partner for Regulatory Affairs Excellence
“We are extremely satisfied with the support and CMC templates provided by Celegence. Thanks to their expertise and the efficiency of the templates, we successfully submitted a business-critical dossier to the EMA with zero major or critical queries – a first for us. This marked a significant improvement compared to past submissions, where major challenges arose without the structured approach Celegence offered. Their collaboration has delivered exceptional results, streamlining our processes, enhancing submission quality, and driving substantial efficiency and cost improvements. We are thrilled with this outcome and look forward to continued success together.”
“Celegence’s tech-enabled services consistently deliver immediate value. Qdossier supported by eCTD submission experts allowed us to cut our publishing time for a full New Drug Application in half. Rework was minimized allowing us to meet aggressive timelines. Customer service responsiveness is top notch. Celegence is the best business partner we’ve had in our 25 years”
Resources to Assist Your eCTD Publishing and Submissions
Contact Us Today
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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