Simplify complex regulatory processes

Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market.

With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients.

“For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including CROSSCHECK and VALIDATE. So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation”

Jessica Pung, MS, RAC
Associate Director of Regulatory Operations, Prelude Therapeutics

View Prelude Therapeutics Case Study

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Meet your organization’s goals on expediting your release to market

As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions as fast and as accurately as possible.

  • CROSSCHECK – Quality control (QC) your hyperlinks and bookmarks 8X faster and 3X more accurate than cumbersome, traditional manual methods
  • LINK – Quickly and accurately generate regulatory compliant PDF documents, process 10 GB of data in minutes, and create 1,000,000 hyperlinks per hour
  • Live validation – Identify and correct your errors in real-time
  • Delta publishing – As last-minute changes are made, only publish the revisions

GlobalSubmit eCTD software streamlines your regulatory workflows and reduces the number of steps you must perform to arrive at a validated submission, expediting your time to market.

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Meet your organization’s goals on expediting your release to market
Confidence and compliance with your eCTD submissions
Confidence and compliance with your eCTD submissions

Certara’s GlobalSubmit eCTD software was created in 2005, and since then, our eCTD software has processed over 1.5 million regulatory submissions.

  • 21 CFR Part 11 compliant
  • Validation provided for you with each release
  • Training provided by regulatory experts
  • Seamless integration with industry leading electronic document management systems (eDMS)
  • Supports investigational and marketing application submissions (IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more)
  • Compile eCTD submissions for various health authorities including:
    • US FDA
    • European Medicines Agency (EMA)
    • Health Canada
    • Swissmedic
    • Australia’s Therapeutic Goods Administration (TGA)
  • Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
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eCTD software and regulatory experts that support your organization as it grows

Certara ensures efficient, timely submissions through our GlobalSubmit eCTD software and Synchrogenix team of regulatory operations and eCTD publishing specialists.

Many of our GlobalSubmit clients utilize our Synchrogenix team when they need to outsource additional support implementing eCTD, during peak filing times, or high-profile submissions that they want to ensure submission success.

GlobalSubmit eCTD software is cloud-hosted, making it easy for our team of regulatory operations and eCTD publishing specialists to provide additional support when you need it the most.

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eCTD software and regulatory experts that support your organization as it grows
Simplify your review process with an anywhere, anytime eCTD viewer
Simplify your review process with an anywhere, anytime eCTD viewer

GlobalSubmit WebReview is a cloud-based eCTD viewer that facilitates an efficient and dynamic regulatory review of your electronic submission process through web-hosted access for all your global activities. Streamline your eCTD review process across your stakeholders with innovative technology that:

  • Provides anytime, anywhere browser access with no IT installation required
  • Empowers your reviewers through an easy-to-use interface to quickly navigate and search through applications in seconds
  • Reduces your risk of costly errors and delays

 

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Ryan
Ryan M. Lanci, MSN, RN, PMP Director, Product Management

Ryan has over 16 years of drug development experience across operations and technology. He is an experienced leader of international and matrixed project and program management, clinical development systems, and process improvement. Ryan serves as the product owner for the GlobalSubmit platform, driving system development and roadmap planning.

Shenell Bailey
Shenell Bailey Manager, Training and Support

Shenell has over 5 years of experience as a regulatory submission specialist with proficiency in quality control and publishing NDAs, INDs, ANDAs, and other applications to various Health Authorities. She serves as the manager of the product support team for the GlobalSubmit Platform, training and onboarding new clients.

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