Dossier Development & eCTD Publishing
CTD Dossier Authoring, Technical Review & Remediation
Axentra provides complete CTD dossier authoring and technical review across Modules 1–5 for U.S., EU, MHRA, TGA, Health Canada, and global submissions. Our team evaluates your CMC, nonclinical, and clinical documentation for consistency, completeness, and ICH compliance—identifying data gaps, formatting issues, and regional discrepancies before submission.
We specialize in dossier remediation for complex or inherited projects, correcting legacy formats, strengthening Module 2 summaries, ensuring alignment with Module 3 data, and preparing a fully coherent dossier package that withstands regulatory scrutiny.
eCTD Publishing, Validation & Submission-Ready Packaging
Axentra manages full eCTD publishing with strict adherence to FDA, EMA, and MHRA technical standards. We structure, compile, and format submissions using compliant XML backbones, validated hyperlinks, bookmarks, and metadata to ensure clean technical validation across all major authority gateways.
Our publishing team handles initial sequences, amendments, supplements, variations, and lifecycle updates—ensuring every sequence is error-free, region-appropriate, and compliant with current regional validation rules (including EU Module 1, UK-specific requirements, and FDA eCTD v4.0 readiness).
Lifecycle Management, Post-Approval Updates & Global Harmonization
Dossier work does not end at submission. Axentra provides complete post-approval support, including sequence management, variations (Type IA/IB/II for EU), annual reports, labeling updates, CMC changes, stability additions, and global harmonization across multiple regions.
We ensure each update is technically aligned, correctly validated, and fully traceable—reducing regulatory risk and maintaining long-term compliance across your entire product lifecycle.