What Is Regulatory Publishing? A Complete 2025 Guide by ECTD Pharma

At its core, regulatory publishing involves transforming scientific and administrative documentation into electronic formats that meet the stringent requirements of health authorities like the MHRA, EMA, and FDA. But it’s more than just formatting documents — it’s a vital link between regulatory strategy and successful product approvals.

In this in-depth guide, eCTD Pharma breaks down everything you need to know about regulatory publishing, why it matters, the different formats and tools involved, and how our consultancy helps companies navigate this critical function with confidence and precision.

Chapter 1: What Exactly Is Regulatory Publishing?

Regulatory publishing is the technical preparation, formatting, and submission of regulatory documents in an electronic format accepted by national and international health authorities. The process ensures that documentation — from clinical trial protocols to marketing authorisation dossiers — meets legal and technical requirements for both initial approvals and lifecycle management.

It includes:

• Formatting documents into required specifications (Word, PDF/A, XML)

• Assigning document metadata and granularity

• Creating compliant structure and navigation (TOCs, bookmarks, hyperlinks)

• Running validation tools to detect submission errors

• Publishing into formats like eCTD, NeeS, or non-eCTD electronic submissions

• Uploading to health authority portals (e.g., MHRA Submissions, FDA ESG)

Effective regulatory publishing requires a deep understanding of both regulatory requirements and publishing technology.

Chapter 2: Why Regulatory Publishing Matters More Than Ever

In today’s digital-first regulatory landscape, the days of paper dossiers are long gone. Most global health authorities now require — or strongly prefer — electronic submissions, especially in eCTD (electronic Common Technical Document) format.

Key reasons why regulatory publishing is essential:

• 📈 Accelerates time to market: Proper publishing helps avoid delays caused by formatting issues or validation failures.

• 🛡️ Ensures compliance: Publishing errors can result in refusals to file or even regulatory penalties.

• 🔍 Improves transparency and traceability: Electronic formats allow authorities to easily review and audit submissions.

• 🔁 Supports lifecycle management: Publishing enables seamless updates to previously submitted dossiers.

• 🧠 Reduces human error: Automated tools catch formatting and metadata mistakes before submission.

At eCTD Pharma, we’ve seen firsthand how high-quality publishing can save clients time, money, and stress during critical submissions.

Chapter 3: Regulatory Publishing Formats You Should Know

Depending on the region and type of submission, health authorities may require different formats. Here’s an overview of the most common ones we support at eCTD Pharma:

1. eCTD (Electronic Common Technical Document)

The gold standard for submissions to the MHRA, EMA, FDA, Health Canada, and other ICH regions. eCTD consists of five modules:

1. Administrative and Product Information

2. CTD Summaries

3. Quality

4. Nonclinical Study Reports

5. Clinical Study Reports

Each document is hyperlinked, bookmarked, and accompanied by an XML backbone to ensure structure and version control.

2. NeeS (Non-eCTD electronic Submissions)

Used in some non-ICH regions or as a transitional format. Less structured than eCTD but still requires proper formatting and organization.

3. Paper-to-eCTD Conversion

Some legacy submissions still exist in paper or scanned format. We help clients digitise and convert these into compliant eCTD sequences.

4. Clinical Trial Applications (CTA / IND)

Early-stage submissions like CTAs (Europe) or INDs (US) must also follow specific formats, depending on the country and product type.

Chapter 4: What Does the Regulatory Publishing Process Involve?

At eCTD Pharma, our regulatory publishing workflow is precise, validated, and quality-controlled. Here’s a typical step-by-step overview:

1. Document Preparation

   • Review for formatting issues (e.g., margins, fonts, headers)

   • Convert Word to PDF/A where required

   • Add bookmarks, hyperlinks, and headers

2. Publishing

   • Organise documents into correct eCTD structure

   • Add metadata (TOC titles, document types, keywords)

   • Generate XML backbone

3. Validation

   • Use in-house or industry-standard tools (Lorenz, Extedo, Freyr SUBMIT PRO) to run compliance checks

   • Fix any errors related to structure, links, file types, etc.

4. QC Review

   • Manual cross-checking of TOC, hyperlinks, module numbers

   • Ensure all files are present and submission-ready

5. Submission

   • Upload to regulatory portals (e.g., MHRA Submission Portal, FDA ESG)

   • Provide confirmation, audit trail, and archive copy to client

Chapter 5: Common Regulatory Publishing Challenges

Regulatory publishing may sound straightforward, but it involves several challenges:

• 🔧 Formatting inconsistencies from authors using multiple templates

• ❌ Validation errors due to incorrect XML generation

• 🧱 Large file sizes that exceed authority limits

• 🔄 Last-minute document updates disrupting publishing timelines

• 🔒 Strict authority deadlines with no room for error

Our team at eCTD Pharma is trained to anticipate and overcome these issues, ensuring your submission is always compliant, validated, and delivered on time.

Chapter 6: How eCTD Pharma Can Help You Succeed

We are not a generalist CRO — eCTD Pharma is a specialist consultancy built for regulatory publishing excellence. Our clients range from startups submitting their first MAA to large pharmaceutical firms needing support for EU and UK variations.

Here’s what sets us apart:

✅ In-house publishing and validation software✅ Fast turnaround times for urgent submissions✅ Affordable pricing for SMEs and start-ups✅ End-to-end project management from planning to submission✅ Trusted experience with the MHRA, EMA, and FDA

We act as an extension of your regulatory team — agile, dependable, and quality-focused.

Chapter 7: Who Needs Regulatory Publishing Services?

Our publishing services support:

• Pharmaceutical companies (branded and generics)

• Biotechnology firms launching novel therapies

• Medical device companies navigating MDR and IVDR

• Supplement brands expanding into regulated markets

• Regulatory consultancies looking to outsource publishing work

Whether you're submitting a new product application or updating your SmPC, we’re here to help.

Chapter 8: Frequently Asked Questions (FAQs)

What software is used in regulatory publishing?

We use in-house publishing tools along with industry-standard platforms like Freyr SUBMIT PRO, Lorenz docuBridge, and Extedo eCTDmanager.

How long does publishing take?

Timelines vary by submission type. A standard eCTD variation can be published within 2–5 days; full MAAs take longer depending on document readiness.

Can eCTD Pharma act as a submission gateway?

Yes. We can publish, validate, and submit on your behalf directly to portals like MHRA, FDA ESG, and EU CESP.

Do you support publishing outside the UK?

Absolutely — we support global submissions across Europe, the US, Canada, Australia, and beyond.

Conclusion: Trust eCTD Pharma for Expert Regulatory Publishing Services

In a world of ever-evolving regulatory standards, expert regulatory publishing is not just a value-add — it’s a requirement. Submissions must be not only complete and accurate but technically flawless to gain timely approval from health authorities.

At eCTD Pharma, we help life science companies turn complex documentation into compliant, validated submissions that get approved — faster and with fewer queries.

📞 Ready to take the stress out of regulatory publishing?Contact us at info@ectdpharma.com or visit www.ectdpharma.com to get started.