Why SharePoint Is Essential for Regulatory Consultancies — And Why ECTD Pharma Ltd Invests in the Best

Tom Marsden
Jul 14
7 min read

In the highly regulated world of pharmaceuticals, biotechnology, and medical devices, trust and precision are everything. As a regulatory submissions consultancy, your clients depend on you to manage their most sensitive data — including investigational dossiers, marketing applications, and post-approval changes — with airtight security, traceability, and speed. At eCTD Pharma, we take this responsibility seriously. That’s why we’ve integrated Microsoft SharePoint into our core infrastructure: a powerful, scalable, and secure collaboration platform trusted by leading enterprises and government agencies across the globe.

But what makes SharePoint so critical to regulatory publishing? Why should a regulatory consultancy invest in tools like this? And how does this translate to better service, faster timelines, and airtight compliance for our clients?

Let’s take a closer look.

The Nature of Regulatory Submissions Demands Precision and Security

Regulatory publishing isn’t just pushing PDFs into an envelope. It’s a meticulous, structured process that involves:

Handling Module 1 to 5 eCTD documents
Ensuring compliance with regional standards (MHRA, EMA, FDA, etc.)
Coordinating input from multiple stakeholders (regulatory affairs, CMC, clinical, QA)
Managing review cycles under tight deadlines
Keeping complete version control and audit trails
Delivering validated, submission-ready sequences to authorities

This complex workflow requires more than email threads and shared drives — it demands a system purpose-built for collaboration, access control, and document lifecycle management. That’s exactly what SharePoint delivers.

Why SharePoint Is the Gold Standard for Collaboration in Regulatory Work

At eCTD Pharma, every client is assigned a dedicated SharePoint workspace with a structured folder system tailored to their submissions pipeline. This allows seamless access to:

Initial submission packages (e.g., CTA, IND, MAA)
IR responses and health authority queries
Post-approval variations
Reference documents, labeling files, and more

Clients and consultants can upload, review, and track progress in real-time — eliminating email attachments and the inevitable confusion of file versioning.

Granular Access Control and Compliance

With SharePoint, we can define precise user permissions — ensuring that only authorized personnel can view, edit, or upload documents. Whether it’s an internal team member, a client’s regulatory lead, or a third-party consultant, we manage access with confidence.

For regulated industries, this kind of control is non-negotiable. It supports 21 CFR Part 11 readiness, EU Annex 11 principles, and good documentation practices (GDocP).

Version Control and Audit Trails

Every document stored in SharePoint automatically tracks versions, edits, and timestamps — creating a transparent audit trail for all changes. Need to revert to an earlier draft? View who approved the latest version? It’s all there.

This is essential for regulatory publishing, where document integrity is not just best practice — it’s a legal requirement.

Secure, Cloud-Based, and Scalable

SharePoint is hosted in Microsoft’s secure cloud infrastructure, offering enterprise-grade encryption, redundancy, and uptime. For clients working across global time zones, SharePoint ensures availability wherever and whenever it’s needed.

At eCTD Pharma, we use this to scale effortlessly — onboarding new clients, managing complex multinational submissions, and maintaining compliance across the UK, EU, and US.

Seamless, Secure File Sharing with Clients — Just One Safe Link Away

At eCTD Pharma, we know that one of the biggest pain points for regulatory teams is the hassle of sharing and tracking files — especially across global teams, external consultants, and tight submission timelines. That’s why we use SharePoint to make the file sharing experience frictionless and fully secure.

With SharePoint, there’s no need to juggle large email attachments, wait for zipped folders, or worry about version mix-ups. Instead, we provide our clients with a simple, secure link to access the exact files they need — whether it’s a draft MAA, validation report, or final eCTD sequence.

How It Works

🔒 You get a secure link: Each client receives a customized SharePoint folder or document library with a unique link.
📁 Granular access control: We set precise permissions (view-only, edit, upload) based on roles — whether you’re the regulatory lead, QA reviewer, or external partner.
🔁 Real-time collaboration: Clients can upload files, leave comments, and see updates as they happen — eliminating the delays of email back-and-forths.
🔄 Always the latest version: Every document is version-controlled, so you’ll never lose track of the most recent file.

Benefits for Our Clients

Speed: No need to wait for email chains or zipped folders — your documents are always ready and organized in one place.
Clarity: Folder structures are tailored to your submission type and region (e.g., MHRA, EMA, FDA), so nothing gets lost or misfiled.
Security: Each link is permission-controlled and can be set to expire, ensuring only authorized users access sensitive data.
Convenience: Access your regulatory files from anywhere, anytime, without needing special software — just a browser.

Whether you’re uploading new Module 3 documents or reviewing a published eCTD sequence, our SharePoint-powered sharing system ensures it’s fast, easy, and secure.

At eCTD Pharma, we’ve removed the friction from collaboration — because we believe clients should spend less time chasing files and more time moving forward.

Cyber Safety and Data Protection: A Non-Negotiable in Regulatory Publishing

When handling confidential regulatory dossiers, client trust hinges not just on accuracy and speed — but also on data security. At eCTD Pharma, we understand that every document we touch contains commercially sensitive information: clinical trial data, manufacturing controls, proprietary formulations, and submission strategies.

That's why we chose SharePoint — not just for its collaboration tools, but for its industry-leading cybersecurity features.

Enterprise-Grade Protection, Built for Regulated Industries

Microsoft SharePoint is backed by Microsoft 365's global security infrastructure, offering:

End-to-end encryption: All files are encrypted both in transit and at rest.
Multi-factor authentication (MFA): Prevents unauthorized access even if credentials are compromised.
Advanced threat detection: Built-in tools monitor for suspicious behavior and alert us to potential risks.
Automatic backups and version history: Protect against accidental deletion or ransomware by rolling back to earlier versions.
Data loss prevention (DLP): Identifies and blocks sensitive data from being shared inappropriately.

This means that even in the face of modern cyber threats — from phishing attempts to targeted ransomware attacks — our clients’ data remains secure, traceable, and recoverable.

How Our Clients Benefit

Our clients don’t need to worry about file security, access control, or document integrity — because we’ve already built it into the system. With SharePoint, you benefit from:

Secure uploads of draft and final documents
Full control over who can see what, and when
Peace of mind that your submission won’t be compromised mid-review
A defensible, auditable trail for regulatory and internal inspections

Whether you're submitting a high-stakes MAA, IND, or responding to a Health Authority IR, your documents are protected by enterprise-grade security every step of the way.

At eCTD Pharma, we believe that trust is built on transparency and security. Our SharePoint platform reinforces both — so you can focus on your submission strategy, not your document safety.

How SharePoint Supports ECTD Pharma’s Regulatory Services

Our business model is built on speed, accuracy, affordability, and trust. SharePoint supports each of these pillars by improving every aspect of the regulatory publishing process.

SpeedInstant access to dossiers, real-time review, and automated alerts reduce turnaround times.

AccuracyCentralized versioning and validation-ready documentation reduce human error.

AffordabilityStreamlined workflows and reduced admin overhead keep costs client-friendly.

TrustSecure, permission-controlled spaces demonstrate our commitment to data integrity.

We’ve seen how fragmented workflows and poor document control lead to delayed submissions, rejected sequences, and even regulatory non-compliance. At eCTD Pharma, we refuse to take that risk — for us or our clients.

Trusted by Industry — Powered by Microsoft

When you partner with eCTD Pharma, you’re not just hiring an outsourced publishing service. You’re gaining a trusted regulatory partner who:

Publishes eCTD sequences to the highest industry standards
Manages submissions in validated tools (Freyr SUBMIT PRO + SharePoint)
Supports UK, EU, and US submissions with global expertise
Communicates clearly, collaborates fast, and protects your IP

Our investment in SharePoint is just one example of how we bring enterprise-grade infrastructure to every client engagement, regardless of company size.

Real-World Example: A Seamless Submission Workflow

Let’s say a client is preparing a Clinical Trial Application (CTA) for submission to the MHRA. Here's how SharePoint enhances that process:

We create a client-specific SharePoint library with subfolders for:
- Module 1 (UK-specific)
- Module 2 summaries
- Module 3 quality
- M4 non clinical
- M5 clinical
- Client uploads & references
The client’s regulatory lead uploads draft documents to the "Client Uploads" folder.
Our consultants annotate feedback directly in SharePoint or download locally and reupload versions.
Once finalized, we publish the submission using our validated eCTD software.
The final published output and validation report are uploaded to the “Final Published Submissions” folder.
If queries are raised by MHRA, the IR responses are tracked in the same workspace, ensuring continuity and control.

No emails lost. No files misplaced. No compliance gaps.

Why Clients Trust Us: The Tech and the Team

Our technology stack includes:

Microsoft SharePoint – secure cloud-based document collaboration
SUBMIT PRO – industry-leading eCTD publishing software
Adobe Acrobat Pro & XMLSpy – for content validation and markup
SUBMIT PRO Validation Tools – to ensure submissions are accepted first time

Our consultants are:

Experts in UK, EU, and US regulatory publishing
Skilled in dossier structure, validation, and authority requirements
Fast, precise, and client-focused
Backed by decades of combined experience

At eCTD Pharma, we don’t just invest in tools. We invest in people who know how to use them to perfection.

Testimonials from Our Clients

“We couldn’t have gotten our MAA over the line without eCTD Pharma’s publishing expertise. Their SharePoint workspace made collaboration simple and transparent.”— Regulatory Affairs Director, Mid-Size UK Biotech

“Fast, reliable, and professional. We had 100% acceptance of our submissions across the EU and MHRA — thanks to their meticulous approach.”— QA & Compliance Manager, Medical Device Company

ECTD Pharma: Your Global Regulatory Partner

In a landscape where compliance is non-negotiable and speed-to-market is everything, ECTD Pharma stands out as a partner who delivers.

Trusted by regulatory authorities
Relied upon by clients worldwide
Invested in tools like SharePoint to deliver top-tier service

We believe that the tools we use reflect the quality we deliver. By integrating SharePoint into our submission process, we’ve empowered our consultants and clients alike — delivering faster timelines, flawless documentation, and exceptional value.