eCTD v4.0 Gap Analysis + Document Prep: How ECTD Pharma Helps You Avoid Costly Rejections

Tom Marsden
6 days ago
2 min read

2026 Is Coming — And Most Teams Are Guessing

January 1, 2026: FDA requires eCTD v4.0. One bad PDF. One broken link. One missing bookmark. → Technical rejection. → Weeks of rework. → Delayed approval.

We’ve seen it:

80% of 2025 pilot issues were document-related. (FDA ESG Validation Trends, Q3 2025)

At ECTD Pharma, we’ve completed 12+ v4.0 gap analyses and document prep projects in 2025. Result: No client has had a technical rejection after our review.

Not magic. Just thorough, practical, human-reviewed work.

Our Service: Gap Analysis + Document Preparation

What We Do	What You Get	Time
Gap Analysis	Full audit of your v3.2.2 → v4.0 gaps	5–7 days
Document Prep	PDF fixes, bookmarks, hyperlinks, metadata	3–5 days
Total Package	Submission-ready module	8–10 business days

Fixed Price: $6,900 (covers one full module or up to 50 docs)

How It Works — Step by Step

1. Gap Analysis

We review every file against FDA v4.0 rules:

Broken links?
Missing study tags?
Non-compliant PDFs?

You get:

Clear report (PDF + Excel)
Prioritized fixes with out strict traffic light system
Risk level (low/medium/high)

2. Document Preparation

We fix what’s broken:

Task	Why It Matters	How We Do It
PDF Compliance	Must be PDF/A-3b	Convert + validate
Bookmarks	FDA expects hierarchy	Auto-build + QA
Hyperlinks	Must work in v4.0	Rebuild with stable URIs
Metadata	Required for lifecycle	Add study tags, keywords
Searchable Text	No scanned images	OCR + verify

You get:

Clean, clickable PDFs
Validation-ready files
ESG test report (we run a mock)

Real Example: What We Fixed for a Client

Client: Small US biotech (IND resubmission) Problem:

38 PDFs
112 validation warnings
Broken hyperlinks, missing bookmarks

Our Fix (9 days):

Gap report → 112 issues mapped
Rebuilt all PDFs + hyperlinks
Ran mock v4.0 submission in ESG

Result:

ESG passed with 3 minor warnings (fixed same day). Client: “Saved us from a 3-week delay.”

7 Common Issues We Fix

Issue	Risk	Our Fix
Scanned PDFs	Not searchable	OCR + retype if needed
Flat bookmarks	Hard to navigate	Full hierarchy
Dead hyperlinks	Validation fail	Rebuild with URIs
Wrong PDF version	Auto-reject	Convert to PDF/A-3b
Duplicate files	Confusion	Dedupe + link
Missing tags	Lifecycle error	Add XML metadata
Font issues	Display errors	Embed all fonts

Free Document Health Check (5 Minutes)

Ask yourself:

Are your PDFs PDF/A-3b?
Do all sections have bookmarks?
Are hyperlinks clickable in a new folder?
Is all text searchable?
Have you tested in ESG?

Not sure? We’ll check one PDF for free!

Why Work With ECTD Pharma?

You Want	We Deliver
Speed	8–10 days
Clarity	Simple reports, no jargon
Price	£49 per document
Support	Around the clock support with lead consultants
Tools	Freyr, Acrobat Pro