eCTD Publishing & Regulatory Operations

At GLORAMP, we deliver high-quality, compliant, and efficient eCTD publishing and regulatory operations that support successful global submissions and lifecycle management.

What We Do

We manage the complete regulatory submission process — from planning to validation — ensuring every sequence meets authority and regional technical specifications.
Our capabilities include:

Submission planning and dossier compilation
Document formatting, QC, bookmarking, and hyperlinking
Lifecycle and sequence management (IND/CTA → MAA/NDA/BLA/ANDA)
Regional publishing to EU, UK (MHRA), EMA, and FDA standards
Final validation and submission readiness checks
Secure archival and audit-ready documentation

Built on validated, high-throughput systems, our operations meet the standards used by leading global publishers and regulatory teams.

Outcomes You Get

Faster authority acceptance and cleaner technical validation logs
Smoother regulatory interactions and timely deficiency responses
Clear, compliant submissions — ensuring accurate information reaches both patients and healthcare professionals

Book a free call

Let’s talk! Book a free 30-minute call with a senior team member to explore how we can support your goals.