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10 Small Submissions

No more than 10 Documents per submission

1 Large Submission

No more than 75 documents per submission

DMS Integrations available

Open Text Documentum, Veeva Vault, and Master Control and Freyr rDMS

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Global Support

Our customer support covers 3 time zones: America, Europe & Africa and Asia

Leading NeeS and eCTD Experts

Experienced publishers who have completed 200,000+ global submissions over the past 12+ years supporting 100s of small-mid Bio Pharma companies and several Top 20 large Bio pharma companies. 24 x 5 global publishing teams across 20 locations.

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Publishing Handyman

Someone to assist you in your submissions journey.

Regulatory Intelligence Access

Our services and technology team are up to date with any Regulatory market intelligence and the transfer of knowledge reflects on the platform swiftly

Free PDF download

Submit Pro GEO

Health Authorities to choose from:

  • USA - U.S. Food and Drug Administration (FDA)
  • Australia - Therapeutic Goods Administration (TGA)
  • Canada - Health Canada
  • Jordan - Jordan Food and Drug Administration
  • Europe - Europe Medicines Agency & All National Agencies
  • Switzerland - SWISSMEDIC eCTD
  • Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan - EAEU eCTD The Eurasian Economic Union (EAEU)
  • Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, Republic of Yemen and United Arab Emirates - GCC eCTD (Gulf Cooperation Council)
  • Thailand - Thailand Food And Drug Administration (Thai FDA)
  • Malaysia – National Pharmaceutical Regulatory Agency (NPRA)
  • Singapore - Health Sciences Authority (HSA)
  • China - The National Medical Products Administration (NMPA)
  • South Africa (ZA) - South African Health Products Regulatory Authority (SAHPRA)

$1450 for every additional HA

If you wish to add more Health Authorities to your bundle, it costs an additional $1450

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  • Health Authority
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      • Understanding USFDA Form 483: Everything You Need to Know
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Blogs

  • Key Updates on TGA’s eCTD 4.0 Rollout
    Key Updates on TGA’s eCTD 4.0 Rollout
    April 18, 2025
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  • Global Regulatory Harmonization Efforts in 2025
    Global Regulatory Harmonization Efforts in 2025
    April 11, 2025
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  • EMA’s Roadmap for eCTD 4.0 - Key Updates and Insights
    EMA’s Roadmap for eCTD 4.0 - Key Updates and Insights
    March 7, 2025
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  • The Future of Regulatory Submissions: Trends to Watch in 2025
    The Future of Regulatory Submissions: Trends to Watch in 2025
    February 6, 2025
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  • Best Practices for Implementing an eCTD Submission Software
    Best Practices for Implementing an eCTD Submission Software
    January 31, 2025
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  • USFDA's eCTD 4.0 Update: Key Takeaways
    USFDA's eCTD 4.0 Update: Key Takeaways
    January 16, 2025
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  • Understanding USFDA Form 483: Everything You Need to Know
    Understanding USFDA Form 483: Everything You Need to Know
    January 8, 2025
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  • The Strategic Advantage of Partnering with the Right eCTD Solution
    The Strategic Advantage of Partnering with the Right eCTD Solution
    December 10, 2024
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  • The Complete Guide to Regulatory Submission Software for Life Sciences
    The Complete Guide to Regulatory Submission Software for Life Sciences
    November 28, 2024
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