eCTD Publishing

Ensure your regulatory submissions are FDA and ICH-compliant with our expert eCTD publishing services. We help pharmaceutical, biotech, and generic drug companies convert, validate, and submit their applications seamlessly.

What We Offer
• Document Conversion & Formatting – Transform Word, Excel, and PDF files into fully compliant eCTD-ready documents with proper bookmarks, hyperlinks, and metadata.
• Validation & Quality Checks – Comprehensive review against FDA/EMA validation rules to prevent errors and delays. • Submission Management – Preparation and publishing of IND, NDA, ANDA, BLA, and DMF submissions with complete Module 1–5 structure.
• Lifecycle Management – Ongoing updates for amendments, supplements, and responses to agency queries.
• Global Support – Publishing compliant with FDA, EMA, Health Canada, and other global health authorities.

Why Choose Us
✔ Affordable pricing – Small submissions starting at $400
✔ Experienced team with proven track record across IND, NDA, ANDA, DMF, and BLA filings
✔ Fast turnaround with guaranteed on-time delivery
✔ End-to-end support from document preparation to final FDA acceptance

Who We Serve
Our services are trusted by:
• Pharmaceutical companies (branded & generic)
• Biotech firms
• Contract research organizations (CROs)
• API and excipient manufacturers

Whether you need help with a single submission or ongoing annual support, our team ensures your eCTD submissions are accurate, compliant, and delivered without delays.