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10 Small Submissions

No more than 10 Documents per submission

1 Large Submission

No more than 75 documents per submission

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

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

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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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Blogs

  • Unlocking Data Privacy and Security: A Game-Changer in Regulatory Submissions
    Unlocking Data Privacy and Security: A Game-Changer in Regulatory Submissions
    September 30, 2024
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  • How Streamlining Your Communication Can Make or Break Your eCTD Submission
    How Streamlining Your Communication Can Make or Break Your eCTD Submission
    August 30, 2024
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  • Top 5 Skills Every Regulatory Affairs Professional Should Have in 2024
    Top 5 Skills Every Regulatory Affairs Professional Should Have in 2024
    August 12, 2024
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  • The Evolution and Future of eCTD tools
    The Evolution and Future of eCTD tools
    July 25, 2024
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  • Streamlining eCTD Submissions with Regulatory Software: A Comprehensive Guide for the Life Sciences Industry
    Streamlining eCTD Submissions with Regulatory Software: A Comprehensive Guide for the Life Sciences Industry
    July 12, 2024
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  • Going Global with eCTD 4.0: Japan Takes the Lead
    Going Global with eCTD 4.0: Japan Takes the Lead
    June 19, 2024
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  • Parallel Submissions in Canada: A Streamlined Path, or a Different Road Altogether?
    Parallel Submissions in Canada: A Streamlined Path, or a Different Road Altogether?
    March 28, 2024
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  • Unlocking the Power of Real-World Data for Regulatory Success
    Unlocking the Power of Real-World Data for Regulatory Success
    November 2, 2023
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  • 21 CFR Part 11: A Trustworthy Cornerstone for Regulatory Submissions
    21 CFR Part 11: A Trustworthy Cornerstone for Regulatory Submissions
    October 6, 2023
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