Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
eCTD Compilation & Publishing
Expert compilation of regulatory submissions in eCTD format (v3.2.2 and v4.0), ensuring compliance with FDA, EMA, and ICH specifications.
IND/NDA/BLA Submissions
Complete publishing services for investigational and marketing applications, including original submissions, amendments, and supplements.
FDA Gateway Transmission
Secure transmission of submissions via the FDA Electronic Submissions Gateway (ESG), with confirmation tracking and acknowledgment management.
Multi-Region Publishing
Publishing services for global submissions including FDA, EMA, Health Canada, and other ICH regions with region-specific formatting.
Document Management
Comprehensive document QC, hyperlinking, bookmarking, and validation to ensure submission integrity and reviewer usability.
Technical Validation
Pre-submission validation using FDA-compliant tools to identify and resolve technical issues before transmission, ensuring first-time acceptance.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Document Receipt & Review
We receive your source documents and conduct an initial review for completeness, formatting requirements, and publication readiness.
eCTD Assembly
Our publishing specialists compile documents into the eCTD structure, applying proper granularity, hyperlinking, and metadata.
Quality Control
Multi-level QC process including technical validation, link verification, and compliance checks against current FDA specifications.
Transmission & Tracking
Secure submission via FDA ESG with real-time tracking, acknowledgment monitoring, and issue resolution if needed.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.