eCTD Dossier Preparation & Global Submissions (EU, UK, US, Canada, Australia)
Why It Matters
The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory dossiers across global agencies. A well-prepared dossier not only ensures compliance but also significantly reduces approval timelines, minimizes queries from authorities, and streamlines lifecycle management.
Our Expertise
We provide end-to-end eCTD dossier preparation, publishing, and global submissions support tailored to regional requirements, ensuring complete compliance with ICH and local guidelines.
Our Services Include
Dossier Compilation & Authoring
- Preparation and review of all modules (Module 1–5) in line with ICH CTD structure.
- Authoring of high-quality summaries, overviews, and reports.
Publishing & Validation
- eCTD publishing using industry-standard tools.
- Validation against EMA, FDA, MHRA, Health Canada, and TGA specifications.
Global Submissions Management
- Initial Marketing Authorization Applications (MAA/NDA/ANDA)
- Variations, Supplements, Amendments, and Lifecycle Management.
- Handling agency-specific requirements (e.g., EU-ASMF, US-DMF).
Gap Analysis & Compliance Review
- Identify deficiencies or missing data prior to submission.
- Ensure adherence to latest agency guidance and regional formatting.
Regulatory Liaison
- Act as a bridge between your team and regulatory authorities.
- Manage queries, deficiency letters, and post-submission responses.
Our Clients
