Simplify complex regulatory processes

The risk of rejection during the submission process can not be taken lightly, especially given the changing and growing complexity of the regulatory environment.

Certara offers the GlobalSubmit™ platform that regulatory operations professionals like you need to efficiently publish, validate and review electronic common technical document (eCTD) submissions.

Eliminate risk and avoid unnecessary steps with a simplified and efficient regulatory process.

  • Efficiently QC and publish regulatory compliant PDF documents
  • Eliminate risk of technical rejection with robust tools to assess the technical validity of your electronic submission
  • Advance the regulatory review of the electronic submission process with identical vantage points between you and the reviewers

What GlobalSubmit users say:

“The system is compliant with the global standards, easy to use and the technical staff is very helpful and guided me through to ensure that I was set up properly and was able to get a production account and start making submissions.” – President of a regulatory consulting company

“I always had a great, kind, friendly and on-time support from our account manager and from the technical support team as well.”‘  – Head of Quality Assurance at top 10 global pharmaceutical company

“Excellent tech support, and the software is user friendly” – Sr. Manager of Regulatory Affairs at biotech company

Innovative 2-step PUBLISH process

Live Validation functionality in the GlobalSubmit PUBLISH application is the innovation driving single instance output processing. Being able to identify and correct errors in real time, and then publish only the changes, is a tangible advantage as your regulatory department races to meet deadlines and deliver treatments to patients.

The ability to auto process regulatory compliant PDF documents is another major innovation in PUBLISH.  These features reduce the number of steps you must perform to arrive at a validated, high-quality output.

Contact us
Check for over 200 error conditions with VALIDATE

GlobalSubmit’s VALIDATE is a web-based application that checks for over 200 error conditions of varying severity levels. No other program provides such comprehensive error detection.

VALIDATE supports the most up-to-date criteria for FDA, European Medicines Agency (EMA), Health Canada, NeeS, Swissmedic, and numerous other regions.  It is designed to  integrate with all existing publishing applications.

VALIDATE supports fully-automated submissions, a recent development at the FDA engineered to speed the drug approval process. Sponsors using an outdated validation platform are now more vulnerable than ever to technical rejection. 

Download brochure
Secure eCTD viewer with anytime, anywhere access

GlobalSubmit’s WebReview eCTD viewer ensures easy access to your applications. Our cloud-powered, web-hosted technology requires no installations and eliminates the need for IT overhead. WebReview’s browser-based access is also platform and browser agnostic, so it functions on all operating systems and browsers.  Key benefits of WebReview include:

  • Reduced IT overhead, requiring no installation
  • Training provided by submissions experts
  • Continuous delivery and enhancements without manual upgrades
  • Searchability across and within submission applications, leafs, and documents
Get a free trial
Robert Connelly Executive Director, Product Development

Rob has over 20 years of experience in life sciences, primarily focused on developing the people, processes and products needed to submit compliant regulatory filings with global health authorities. He leads development of the  eCTD GlobalSubmit platform.

Shenell Bailey Senior Regulatory Submission Specialist

With over 5 years of experience as a regulatory submission specialist, Shenell manages and maintains regulatory submissions as well as serves as a direct point of contact for clients.  She also performs publishing, QC, and internal review of submission documents.