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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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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

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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

  • eCTD Submissions Planning & Tracking: A Key to Successful Submissions
    eCTD Submissions Planning & Tracking: A Key to Successful Submissions
    January 13, 2023
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  • Automation: A Helping Hand While Transitioning to eCTD 4.0
    Automation: A Helping Hand While Transitioning to eCTD 4.0
    January 4, 2023
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  • eCTD and CTD Filing Procedures for the US and Canada – Challenges & How to Avoid Them?
    eCTD and CTD Filing Procedures for the US and Canada – Challenges & How to Avoid Them?
    December 23, 2022
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  • Getting Ready for Adoption of eCTD 4.0
    Getting Ready for Adoption of eCTD 4.0
    November 29, 2022
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  • Streamlining Regulatory Submissions Through Data
    Streamlining Regulatory Submissions Through Data
    November 11, 2022
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  • eCTD 3.2.2 Vs. eCTD 4.0 - How Significant is the Change?
    eCTD 3.2.2 Vs. eCTD 4.0 - How Significant is the Change?
    October 13, 2022
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  • Revolutionize Regulatory Publishing & Submission with Automation
    Revolutionize Regulatory Publishing & Submission with Automation
    April 27, 2022
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  • Regulatory submission software - key considerations to choose
    Regulatory submission software - key considerations to choose
    September 16, 2021
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  • Throwback 2018 – the regulatory summary in a nutshell
    Global Regulatory submission and Ideal eCTD software
    May 7, 2021
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