ECTD Pharma’s Proven 6-Step Regulatory Publishing Process: Speed, Precision & Security You Can Trust

Tom Marsden
Jul 16
4 min read

At ECTD Pharma, we’ve built a boutique regulatory publishing consultancy designed to deliver fast, flawless, and fully compliant eCTD submissions. But unlike a large CRO, we don’t treat you like a number. We treat you like a partner. We take the time to understand your product, your timelines, your market, and your success goals — and we bring deep regulatory expertise and a powerful suite of technologies to make it happen.

Whether you're preparing a marketing authorisation application (MAA), investigational new drug (IND) application, variation, or lifecycle update, our 6-step regulatory publishing process is designed for one thing: to help you get to market faster, safer, and without stress.

Why Process Matters in Regulatory Publishing

Too often, regulatory publishing is treated as a last-minute technical task. But in reality, it's a high-stakes discipline — one that demands:

Deep regulatory knowledge across multiple markets
Document formatting and metadata mastery
Agency-specific structural expertise
Use of validated software and security protocols
Clear, traceable workflows
Seamless communication with sponsors and stakeholders

At eCTD Pharma, we combine senior-level publishing expertise with a transparent and secure process to ensure your submission isn’t just completed — it’s completed correctly, on time, and ready for approval.

Step 1: Strategic Onboarding & Project Planning

We begin each project with a structured onboarding session. You’re introduced to your dedicated publishing consultant — not an account manager, not a faceless team — but a real expert who will own your submission from start to finish.

We define:

The regulatory scope and timeline
Regional authority formats (FDA, EMA, MHRA, Swissmedic, etc.)
Your SharePoint collaboration folder
Secure file-sharing protocols
Document delivery timelines and expectations

This phase sets a clear path to success and aligns everyone before a single file is touched.

Step 2: Document Preparation & Formatting

Your documents are reviewed and formatted using our AI-assisted document preparation tools, ensuring:

Correct file naming, metadata, bookmarks, and hyperlinks
PDF compliance with agency standards
Compression and splitting of large files
Elimination of validation triggers
Perfect table of contents and structure

Because our tools are built around speed and compliance, we catch problems before they become delays — saving you valuable time and revision costs.

Step 3: eCTD Compilation & Structural Assembly

Using the industry-leading Freyr SUBMIT PRO platform, our team compiles your submission into a fully compliant eCTD structure.

We:

Build your full M1–M5 framework
Apply all regional requirements
Assign metadata and XML files
Check cross-referencing and folder structure
Create reusable templates for future sequences

Thanks to our in-house experience and software automation, we consistently meet even the most aggressive deadlines — without compromising quality.

Step 4: Technical Validation & Quality Review

Before we send or deliver a submission, we run a full validation cycle using Submit PRO’s robust validation engine, checking:

Bookmarks
Links
Envelope metadata
Module granularity
Document consistency

Then, our senior QA experts review everything line-by-line. This double-layer of validation ensures your submission won’t get kicked back due to technical non-compliance.

You also receive a full validation report and QA summary — so you know exactly what was done, when, and by whom.

Step 5: Submission or Secure Client Delivery

We offer two options — both secure, both supported:

Direct submission to authorities via MHRA, EMA, FDA ESG, etc.
Delivery of a validated, submission-ready package via SharePoint

With every project, we also provide:

Transmission receipts (if submitted)
File manifest and audit log
Validation summary
Regulatory envelope and lifecycle mapping

Everything is stored in your dedicated, secure SharePoint workspace — backed by Microsoft’s industry-leading encryption, access control, and version history.

Step 6: Lifecycle Management & Ongoing Support

Unlike many CROs who hand off the job after submission, we continue supporting your product over time:

Prepare variations, renewals, PSURs, DSURs
Submit responses to authority questions (RTQs)
Track cumulative sequences and eCTD lifecycle
Re-use previously submitted content where possible
Maintain submission consistency across regions

This lifecycle partnership saves clients time, reduces rework, and improves regulatory confidence across markets.

Technology You Can Trust

We’ve invested in a suite of top-tier tools to ensure our clients get the best of both worlds — human expertise and tech-driven efficiency:

SharePoint — Secure cloud collaboration with MFA, versioning, audit trails, and simple link-based file exchange
In house SUBMIT PRO — Powerful eCTD publishing and validation platform used by global pharma
AI Document Prep Tools — Auto-format, verify, and enhance compliance on all documents
Submission Templates — Tailored for FDA, EMA, MHRA, Swissmedic, and more
Real-time dashboards and change tracking — See your project’s progress in real time

With eCTD Pharma, your submission is backed by the same infrastructure trusted by major pharmaceutical companies — but with a personal touch and faster turnaround.

SharePoint: A Game-Changer for Secure, Client-Centric Collaboration

One of our biggest strengths is how we work with our clients — not just for them.

Each client gets a private SharePoint workspace with:

Secure folder sharing
Role-based access permissions
Real-time alerts and version tracking
Simple file upload via unique link
Controlled document expiry for added security

You no longer have to send sensitive files via email or guess which version is current. With SharePoint, everything is centralised, transparent, and protected.

We’re Not a CRO. We’re Your Regulatory Partner.

At ECTD Pharma, we don’t have bloated project teams or layers of admin overhead. We’re lean, focused, and driven by a single goal: helping our clients succeed.

You’ll never be just a job number
You’ll work directly with expert directors and consultants
You’ll always know where your submission stands

We understand the urgency of getting products to market. We know how critical compliance and timing are. And we’ve built our business around delivering what CROs often can’t: agility, clarity, trust, and deep regulatory knowledge.