When Every Other Consultancy Said “No,” We Stepped In — And Delivered a flawless Regulatory Affairs Publishing Success

Tom Marsden
Nov 26
5 min read

Our story begins with a specialised pharmaceutical company preparing a major MAA for the European market. They were nearing the final stages of dossier preparation, but the content they had assembled internally was fragmented, inconsistent, and incomplete. They knew they needed:

a full gap analysis of their documentation
corrective guidance
clean structuring
and complete Regulatory Affairs Publishing into an agency-ready eCTD format

It was urgent.It was technical.It required expertise and capacity.

And that combination caused consultancy after consultancy to decline.

Some said the timeline was too tight.Some lacked the publishing experience for this type of product.Others feared the risk of inheriting a partially built, non-compliant dossier.

By the time the client reached us, the message was simple:

“We’ve tried everywhere else. We’re running out of options. Can you help?”

Why They Chose eCTD Pharma

From the first conversation, the client recognised something different about our approach.

At eCTD Pharma, we are not a large CRO with layers of hierarchy and long decision pathways. Nor are we a small agency that only handles low-risk, low-complexity work. We sit in a rare and powerful space:

✔ A specialist regulatory operations consultancy

✔ With 40+ years combined experience in Regulatory Affairs Publishing

✔ Offering boutique-level care with industry-leading capability

We have undertaken thousands of submissions across global markets. We understand the nuances of EMA, MHRA, FDA, and other regulatory bodies. And we know how to take a fragmented dossier and transform it into a compliant, cohesive, technically flawless submission.

So we did what we always do when a company truly needs us:We made room.

We took on the project.We committed to delivering it right the first time.And we set out to leave no stone unturned.

Phase 1: Full Gap Analysis — The Foundation of Regulatory Affairs Publishing Done Properly

The first stage of this project was to strip the dossier down to its foundations and perform a full gap analysis across all modules of the electronic Common Technical Document (eCTD).

This included:

Module 1: Administrative information

Module 2: Overviews & summaries

Module 3: Quality (CMC)

Module 4: Non-clinical study reports

Module 5: Clinical study reports

Every document had to be assessed for:

completeness
format compliance
structural correctness
style uniformity
version control
data integrity
hyperlinks and bookmarks
alignment with the eCTD model
agency-specific expectations

Where many consultancies had feared the complexity, our team approached it methodically.

One module at a time.One document at a time.One requirement at a time.

This is where the strength of specialist Regulatory Affairs Publishing becomes clear: you must combine scientific understanding, regulatory logic, technical publishing skill, and agency expectations into a single, cohesive workflow.

Our final gap analysis report gave the client something they had not seen in months:

clarity.

Clear missing items.Clear corrections needed.Clear requirements for agency compliance.Clear recommendations.Clear pathway to submission.

Within days, the uncertainty disappeared — replaced by a structured plan and confidence.

Phase 2: The eCTD Build — Where Precision Matters Most

Once the gaps were filled and the documentation consolidated, the next phase was the heart of the project: the full Regulatory Affairs Publishing and eCTD build.

Using our own in-house publishing software — powered by a leading global regulatory technology platform — we rebuilt the entire dossier using:

strict leaf naming conventions
complete hyperlinking
deep navigation structure
bookmarks across clinical and non-clinical studies
metadata population
ESG and gateway compliance requirements
XML backbone creation
lifecycle management tagging
validation preparation

Publishing isn’t simply assembling files.It is the careful engineering of a regulatory “machine” that must work flawlessly.

Every hyperlink had to function.Every file had to meet technical standards.Every module had to be structured perfectly.Every document required correct granularity.Every sequence had to align with lifecycle rules.

This is the work that is invisible when done well — and painfully visible when done poorly.

And it is where eCTD Pharma’s commitment to leaving no stone unturned makes all the difference.

Phase 3: Validation — Passed First Time, Zero Errors

After the final build was completed, we performed extensive validation using our in-house tools and industry-standard compliance checkers.

This stage is where many submissions fail — often due to technical oversights that could have been avoided with proper publishing discipline.

But this dossier passed first time.

No errors.No warnings.No structural issues.No broken hyperlinks.No missing metadata.

For the client, this meant:

No rework
No regulatory delays
No wasted budget
No missed commercial windows

This is what Regulatory Affairs Publishing done properly looks like.

Phase 4: Approval & Launch — The Reward of Getting Publishing Right

With the submission validated and accepted, the product quickly moved through review. Shortly after approval, it entered the market — and began performing strongly.

Today, the client describes the launch as one of the smoothest in their history. The quality of the submission enabled them to move quickly, avoid delays, and capture early commercial momentum.

This was not just a regulatory victory.It was a business victory.

And it was all made possible because they chose the right Regulatory Affairs Publishing partner at the moment it mattered most.

What This Case Reveals About the Future of Regulatory Affairs Publishing

This project highlights a shift happening industry-wide:

1. Regulatory Affairs Publishing is becoming more complex — not less.

Global regulations continue to evolve. eCTD requirements expand. Validation rules tighten. Agencies are less forgiving of technical errors.

2. Capacity is increasingly limited.

Large CROs often deprioritise small to mid-sized companies. Meanwhile, smaller consultancies often cannot handle complex dossiers.

3. High-quality publishing is a competitive advantage.

Fast, clean, compliant submissions lead directly to faster approvals — and faster market access.

4. The demand for specialist consultancies is rising.

Companies that can combine flexibility, expertise, and publishing capability are becoming essential partners in the new regulatory era.

Why eCTD Pharma Leads in Regulatory Affairs Publishing

This case is just one example of our work — but it represents the standard we hold ourselves to.

✔ 40+ years of combined experience

✔ Thousands of global submissions

✔ Industry-leading publishing technology

✔ Boutique service with big-CRO expertise

✔ Exceptional quality, speed, and compliance

✔ Commitment to leaving no stone unturned

We support pharmaceuticals, biologics, medical devices, ATMPs, consumer health, and more — across the full regulatory lifecycle.

Whether it’s a single variation or a 20-year legacy dossier rebuild, we approach each project with the same precision and care.

Because to us, Regulatory Affairs Publishing is not a task.It is a craft.

A Final Message to the Industry

If your organisation is preparing a submission — whether it’s an MAA, NDA, BLA, CTA, ANDA, or a complex variation — the quality of your Regulatory Affairs Publishing will define your success.

Do not let technical errors, structural issues, or capacity limitations slow you down.

Choose a partner who understands: