eCTD Publishing and Submission Services
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes, DDReg delivers efficient dossier conversion and regulatory publishing services that meet global guidelines.
DISCOVER MORETransforming eCTD Regulatory Submissions
DDReg offers a complete suite of services that convert paper INDs, NDAs, and DMFs into the mandatory electronic CTD format. While some regions still accept paper submissions, modern regulatory authorities require technical compliance through eCTD. Our solution includes compiling the baseline sequence—whether as an eCTD dossier or NeeS—and performing a thorough technical assessment against ICH specifications to validate every submission.
Our state-of-the-art tools ensure that every dossier conversion adheres to the latest regulatory guidelines. By leveraging fully validated, 21CFR part 11 compliant eCTD tools, we provide seamless digital publishing and submission services. This enables efficient eCTD submission through agency web portals or gateways while ensuring each marketing authorization application meets technical standards.
Modernizing eCTD Regulatory Processes
eCTD publishing is more than just converting documents; it is about creating a structured, modular format that enhances the traceability and accessibility of regulatory data. The modular “granularity” of the eCTD format improves data quality, reduces errors, and expedites the review process. This shift from paper-based submissions to digital methods signifies a major step forward in regulatory submission services.
Embracing digital transformation through our eCTD submission services minimizes administrative burdens and enhances communication between pharmaceutical companies and regulatory agencies. By aligning with global best practices, our approach supports faster regulatory reviews and ultimately fosters a collaborative environment between industry stakeholders and authorities.
Our eCTD Publishing and Submission Expertise
- Legacy dossier conversion to CTD (NeeS or electronic CTD)
- Publishing initial applications, query responses, variations, and aggregate reports using validated eCTD tools
- eCTD submissions through agency web portals or dedicated gateways
- Maintaining product-specific filing sequences for initial submissions and query responses
- Support for eCTD v4.0 compliance
- Technical assessment of dossiers against ICH specifications
- Utilization of fully compliant digital tools that meet 21CFR part 11 standards
Ready to revolutionize your regulatory submissions and ensure global compliance?