Expertise Across All Markets

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At eCTD Pharma, we specialize in global eCTD submissions, ensuring compliance with regulatory authorities worldwide. With extensive experience handling FDA, EMA, MHRA, Swissmedic, Health Canada, ROW (Rest of World), and NeeS submissions, we help pharmaceutical, biotech, and medical

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United Kingdom – MHRA Submissions

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As a UK-based eCTD submission consultancy, eCTD Pharma is uniquely positioned to manage MHRA regulatory submissions effectively. Since Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new submission pathways that differ from EMA requirements. Many companies struggle with:

• Understanding the evolving post-Brexit MHRA regulatory framework

• Complying with UK-specific submission formats and timelines

• Managing separate submissions for the UK and EU markets

MHRA often prefers to work with UK-based eCTD service providers due to:

• Deep understanding of UK regulatory expectations and post-Brexit changes

• Familiarity with national submission requirements and approval timelines

• Ability to efficiently handle UK lifecycle submissions and variations

At eCTD Pharma, we ensure full MHRA compliance, providing seamless eCTD submissions that align with the latest UK regulations, helping companies navigate Brexit complexities with ease.

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United States – FDA Submissions

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The U.S. Food and Drug Administration (FDA) has strict requirements for eCTD submissions, covering Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs). Common industry challenges include:

• Frequent technical rejections due to formatting issues

• Complex lifecycle management requirements

• Strict validation criteria for hyperlinks, bookmarks, and metadata

At eCTD Pharma, we have a proven track record of successfully publishing FDA submissions with zero technical rejections, ensuring faster approval timelines.

European Union – EMA & National Agencies

The European Medicines Agency (EMA) requires stringent eCTD formatting, and each national competent authority may have additional specifications. Key challenges for companies include:

• Variability in submission requirements across EU member states

• Strict validation and granularity expectations

• Management of complex MAA (Marketing Authorization Application) submissions

Our expertise ensures smooth EMA & national authority submissions, avoiding common pitfalls such as incorrect dossier structures and validation errors.

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Switzerland – Swissmedic Submissions

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Swissmedic follows eCTD standards but maintains unique national requirements. Many companies struggle with:

• Specific submission formats and regulatory pathways

• Document translation requirements

• Lifecycle tracking and variation submissions

With eCTD Pharma, your Swissmedic submission will be fully compliant and optimized for acceptance on the first attempt.

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Canada – Health Canada Submissions

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Health Canada has transitioned to mandatory eCTD for key submission types, requiring precise adherence to:

• Canadian Module 1 specifications

• Bilingual (English & French) regulatory requirements

• Frequent guidance updates and evolving eCTD standards

At eCTD Pharma, we stay ahead of regulatory changes to ensure error-free, fully compliant Health Canada submissions.

 

 

NeeS & Rest of World (ROW) Submissions

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For countries that still accept NeeS (Non-eCTD electronic Submissions) or require specific national formats, companies often face:

• Diverse submission requirements across different health authorities

• Challenges converting from NeeS to eCTD for lifecycle management

• Technical inconsistencies in non-standardized markets

We provide seamless submission solutions for ROW markets, ensuring compliance with each country's specific electronic submission requirements.

Why Choose eCTD Pharma for Global Submissions?

With 40+ years of experience and over 5,000 successful global submissions, eCTD Pharma guarantees:

• Flawless eCTD/NeeS submissions across all markets

• Regulatory intelligence expertise to navigate country-specific requirements

• Proactive validation and quality checks to eliminate submission errors

• Faster approvals and reduced agency queries

Partner with eCTD Pharma for Worldwide Compliance

Whether you need FDA, EMA, MHRA, Swissmedic, Health Canada, NeeS, or ROW submissions, our expert team ensures 100% compliance and efficiency. Contact us today to discuss how we can streamline your global regulatory strategy.