Mastering NeeS Submissions: Your Complete Guide to Global Regulatory Success

While the eCTD (electronic Common Technical Document) format has become the gold standard for regulatory submissions worldwide, the NeeS (Non-eCTD electronic Submissions) format continues to play a vital role in several markets. Companies entering these markets must understand the nuances of NeeS submissions and partner with experienced regulatory publishers to streamline their submission strategies.

At eCTD Pharma, we specialise in global regulatory publishing, including comprehensive NeeS submission services. Our expertise ensures your dossiers meet every regional standard while reducing the risk of compliance errors, submission delays, and additional costs. In this article, we’ll explore what NeeS submissions are, where they’re used, and how a trusted regulatory partner can ensure your success.

What Are NeeS Submissions?

NeeS, or Non-eCTD electronic Submissions, is a submission format accepted by several health authorities worldwide. Unlike eCTD, which uses a complex XML backbone to organise and validate documents, NeeS submissions are simpler, consisting of a structured PDF dossier without an XML backbone. They offer a digital alternative to paper submissions and provide an easier way for companies to transition from paper to electronic submissions.

Although eCTD is now mandatory in many regions, NeeS remains important in specific markets where eCTD requirements are not yet fully implemented or when certain submission types are allowed in NeeS format.

Why NeeS Still Matters

Many companies focus heavily on eCTD, but NeeS submissions remain critical for global regulatory strategies. Here’s why:

1. Market Access Flexibility: Countries that haven’t fully transitioned to eCTD still rely on NeeS, making it essential for accessing these markets.

2. Cost-Effective Transition: For smaller companies or markets, NeeS submissions offer a simpler, more affordable entry point than full eCTD.

3. Legacy Product Support: Many older dossiers exist only in NeeS format, requiring skilled publishers to maintain and update submissions.

4. Streamlined Review Process: NeeS submissions offer authorities a clear, structured electronic dossier, which improves efficiency compared to paper submissions.

   
   

Global NeeS Submission Coverage

At eCTD Pharma, we bring years of experience supporting NeeS submissions for clients in a wide range of markets. Our expertise ensures that your submission is formatted, validated, and published in line with local requirements, eliminating compliance risks. Here’s a snapshot of where and how we help:

1. European Union: NeeS Module 1 Specifications & Validation

While most centralised and decentralised procedures in the EU require eCTD, certain submissions such as PSURs, renewals, and Type IA variations can still be filed in NeeS format. Our team ensures full compliance with EMA and national agency specifications, leveraging rigorous validation tools to prevent technical rejection.

2. Australia & New Zealand: Complete Regional NeeS Compliance

Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe continue to support NeeS submissions. We provide:

• Optimised dossier structure for local regulatory expectations.

• Seamless lifecycle management.

• Validation checks tailored to TGA and Medsafe requirements.

  
  

3. GCC & Saudi Arabia (SFDA): Regional Knowledge and Expertise

With growing regulatory harmonisation efforts in the Gulf Cooperation Council (GCC), NeeS remains accepted for certain submissions. Our specialists bring deep knowledge of SFDA specifications, helping companies navigate local nuances with confidence.

4. Bosnia & Herzegovina: Full ALMBiH Submissions Management

As one of the few European countries still reliant on NeeS, Bosnia & Herzegovina’s Agency for Medicinal Products and Medical Devices (ALMBiH) has unique requirements. We deliver complete dossier management for submissions, renewals, and variations in NeeS format.

5. Canada: CTA Submissions in NeeS Format

Health Canada supports NeeS format for Clinical Trial Applications (CTAs) and certain regulatory updates. Our publishing team ensures seamless document preparation and lifecycle management for Canadian submissions.

The Challenges of NeeS Submissions

Although NeeS may seem simpler than eCTD, it brings its own challenges that can lead to delays and regulatory pushback if not handled properly:

• Inconsistent Requirements Across Regions: Each health authority has its own interpretation of NeeS standards, requiring tailored publishing expertise.

• Lifecycle Complexity: Maintaining multiple NeeS sequences across global markets can be difficult without robust systems.

• Technical Validation Gaps: Unlike eCTD, NeeS submissions do not have automated XML validation, increasing the reliance on skilled publishers.

• Transition Planning: Many authorities plan to phase out NeeS, requiring companies to prepare for future eCTD conversions.

These challenges underscore the importance of having an experienced regulatory partner to manage your submissions with precision.

How eCTD Pharma Makes NeeS Submissions Seamless

At eCTD Pharma, NeeS publishing is part of our core expertise. We understand the intricacies of global regulatory requirements and offer a structured process to ensure every submission is compliant and on time. Here’s how we do it:

1. End-to-End Project Management

We manage every stage of your NeeS submission, from initial planning and document QC to publishing, validation, and delivery to health authorities.

2. Expert Publishing Team

With decades of combined experience in NeeS and eCTD submissions, our publishing team understands both legacy requirements and emerging regulatory trends.

3. Seamless System Integration

Our Freyr SUBMIT PRO system supports multiple formats, including NeeS and eCTD, providing a centralised platform for all your submissions.

4. Lifecycle Support

We maintain, update, and transition NeeS sequences to eCTD when needed, ensuring a smooth regulatory lifecycle.

5. Cost-Effective Solutions

Our pricing is transparent and competitive, offering significant savings for companies managing multiple global submissions.

The Future of NeeS: Preparing for Full eCTD Adoption

While NeeS remains relevant, the industry is moving steadily toward universal eCTD adoption. Health authorities in many regions are setting timelines for mandatory eCTD submissions, meaning companies should:

• Plan Early: Build a strategy for migrating NeeS sequences to eCTD.

• Invest in Technology: Use publishing systems capable of supporting multiple formats.

• Leverage Expert Support: Partner with regulatory consultants who understand both legacy and future requirements.

Our team helps clients not only achieve compliance today but also prepare for the regulatory landscape of tomorrow.

Why Choose eCTD Pharma?

We are more than a regulatory publishing provider – we are your strategic partner. Here’s what sets us apart:

• Specialised Expertise: Decades of combined experience in NeeS, eCTD, and global submissions.

• Global Coverage: Comprehensive understanding of market-specific requirements across Europe, GCC, Australia, Canada, and beyond.

• Proven Track Record: Successful delivery of thousands of submissions, from small lifecycle updates to major marketing authorisation applications (MAAs).

• Client-Focused Approach: We provide tailored solutions that align with your regulatory strategy, timelines, and budget.

• Scalable Support: Whether you’re a startup or a top-10 pharmaceutical company, we offer flexible solutions to meet your needs.

  
  

Conclusion: Make NeeS Submissions Simple, Compliant, and Future-Ready

In a rapidly evolving regulatory environment, companies can’t afford mistakes or delays in their submissions. NeeS remains a crucial format for global market access, and partnering with a team that understands its intricacies is key to your success.

At eCTD Pharma, we combine expertise, cutting-edge technology, and a client-first approach to make your NeeS submissions seamless and compliant. Whether you need a single submission, ongoing lifecycle management, or strategic support for global regulatory operations, we’re here to deliver.

Contact us today to discuss your NeeS and eCTD needs, and let us help you simplify complexity while staying ahead of regulatory trends.