Regulatory Publishing and Submissions

Streamline Your Dossier Submissions Process Without Sacrificing Quality or Accuracy

Streamlining Global Compliance

From intricate timelines to fluctuating submission volumes and diverse regional requirements, the journey towards compliance is riddled with obstacles.

Celegence steps in as your global partner, offering a comprehensive perspective that alleviates the burden of regulatory publishing and submissions.

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Key Solutions to Your Regulatory Challenges and eCTD Submissions

Unrivaled Quality Assurance

Enjoy peace of mind knowing your submissions are accurate the first time. Our solutions deliver a 99% first-time acceptance rate by Health Authorities, ensuring compliance with >95% accuracy over manual processes.

AI-Enabled Efficiency

Imagine doubling your submission efficiency. With Dossplorer™, our AI technology, you achieve up to 4x faster submissions compared to manual processes, cutting time and costs in half while focusing on other critical functions.

Swift Expert Solutions

Benefit from quick and accurate dossier submissions. With our expertise, you can rest assured that your submissions are handled swiftly and are right the first time.

Cost-Effective Compliance

Say goodbye to budget overruns and unexpected expenses with our highly efficient and cost-effective solutions.

Industry Leaders Trust Celegence

Global Organizations Rely on Us for eCTD Submissions

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Celegence - Novartis - Life Science Regulations

Bausch Health - Life Science Regulations

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Resources to Assist Your eCTD Publishing and Submissions

Publishing and Submission Brochure

Dossplorer Brochure

Lean Authoring Checklist

Comprehensive Offerings for Your Regulatory Publishing and Submissions Needs

Dossier Submission: Services to multiple health authorities.
NeeS to eCTD: Conversions aligned with global health authority formats.
Regional & National: Regulatory intelligence services to interpret regional and national submission requirements.
Quality Checks: Comprehensive quality checks and adherence to predefined SLAs.
BPaaS Model: Extension of in-house publishing teams with our Business Process as a Service (BPaaS) model.
End-to-End Service: For Publishing, Submission, and Archival of Dossiers across multiple regions.
Adverse Event Reports: Management and submission of IND Safety & Adverse Event Reports.
Document Formatting and Publishing: Including Word Style Guides and PDF Navigation.

Your Trusted Partner for Regulatory Affairs Excellence

“We specialize in providing dossier submission services worldwide, catering to both eCTD and Non-eCTD electronic submissions (NeeS). ”

At Celegence, we specialize in providing dossier submission services worldwide, catering to both eCTD and Non-eCTD electronic submissions (NeeS). Backed by our seasoned regulatory intelligence team, we ensure compliance and efficiency at every step.

From initial dossier development to seamless interactions with health authorities our solutions streamline your end-to-end submissions management process.

Step 1

Initial Dossier Development

Step 2

eCTD Validation

Step 3

Health Authorities Interaction

Completed

Final Submission Dossier

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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