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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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Blogs

  • May the Publishing Force be with your submissions. Rise above the rest!<p>In today's rapidly evolving pharmaceutical landscape, regulatory compliance plays a pivotal role in ensuring medicinal products' safety, efficacy, and timely availability. Regulatory submissions are critical to this process, requiring pharmaceutical companies to navigate complex frameworks and meet stringent requirements.&nbsp;</p>  <p>The global regulatory affairs market is expected to reach $27 billion by 2030, growing at a compound
    May the Publishing Force be with your submissions. Rise above the rest!
    September 5, 2023
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  • Rise Above eCTD 4.0 Challenges: Equipping Countries for Regulatory Excellence
    Rise Above eCTD 4.0 Challenges: Equipping Countries for Regulatory Excellence
    August 8, 2023
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  • Driving Innovation: Import and Integration Functionality in Regulatory Submissions Software
    Driving Innovation: Import and Integration Functionality in Regulatory Submissions Software
    July 18, 2023
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  • Innovate, Evolve, Succeed: How New Features Transform the Submissions Game from Good to Great
    Innovate, Evolve, Succeed: How New Features Transform the Submissions Game from Good to Great
    June 30, 2023
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  • Embracing the Future: Singapore's Advent into eCTD Submissions
    Embracing the Future: Singapore's Advent into eCTD Submissions
    June 5, 2023
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  • Navigating Regulatory Submission Hurdles:  Tips for Small & Midsize Life Sciences Businesses
    Navigating Regulatory Submission Hurdles:
    Tips for Small & Midsize Life Sciences Businesses
    May 12, 2023
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  • Revamp Your FDA Compliance Game with a Submission Software: Here's How!
    Revamp Your FDA Compliance Game with a Submission Software: Here's How!
    April 20, 2023
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  • Mastering eCTD Submissions: Best Practices for Streamlined Regulatory Approval
    Mastering eCTD Submissions: Best Practices for Streamlined Regulatory Approval
    April 7, 2023
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  • Submission Excellence: Get New Products to Market Faster
    Submission Excellence: Get New Products to Market Faster
    February 23, 2023
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