Synchrogenix Information Strategies, Inc.  

Wilmington,  DE 
United States
http://www.synchrogenix.com
  • Booth: 1117

Profile

For life science companies worldwide seeking the highest quality-oriented partner, Synchrogenix is the added-value provider of customized regulatory solutions with a proven record of success. With over 90% repeat business and 33 years of experience, our expert operations, consulting, and communications teams, along with our reliable technology, ensure successful submissions, enable clients to communicate with confidence, and guide partners through the global regulatory maze.

As a Certara Company, Synchrogenix provides integral regulatory science and strategy expertise to advance Certara’s mission to enable superior drug development and patient care decision-making. With Synchrogenix as a partner, Certara has supported over 90% of U.S. FDA novel new drug approvals for the fourth consecutive year.

For life science companies worldwide seeking the highest quality-oriented partner, Synchrogenix is the added-value provider of customized regulatory solutions with a proven record of success. With over 90% repeat business and 33 years of experience, our expert operations, consulting, and communications teams, along with our reliable technology, ensure successful submissions, enable clients to communicate with confidence, and guide partners through the global regulatory maze.


 Products

  • GlobalSubmit WebReview eCTD viewer
    Synchrogenix's GlobalSubmit WebReview facilitates an efficient and dynamic regulatory review of the electronic submission process by providing Cloud-powered, web-hosted access for all your global activities. Visit Booth #1117 for a product demonstration!...

  • Visit Synchrogenix in Booth #1117 for a WebReview Product Demonstration!

    Simplified Submission Review for a Complex Regulatory World

    Reviewers are often tasked with approving submission content and fielding agency questions, which requires referencing in-stream as well as historical submissions. Without modern technology, easy access, and a single source of truth, simple yet critical review tasks can be delayed because of under-performing eCTD viewing software.

    Synchrogenix’s GlobalSubmit WebReview facilitates an efficient and dynamic regulatory review of the electronic submission process by providing Cloud-powered, web-hosted access for all of your global activities.

    A Simple, Secure Solution with Anytime, Anywhere Access

    WebReview eCTD viewer ensures easy access to your applications. 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 is fully functioning on all operating systems and browsers.

    Features:

    • Usability - Friendly user interface (UI) combined with an intuitive user experience (UX) allows reviewers to quickly navigate and search through applications.
    • Speed - Dynamic opening of applications and large documents facilitates faster review.
    • Scalability - Easily scalable to accommodate larger audience reviews for peak times. 
    • Multiple Views - View your application's cumulative, sequence, current, and regulatory activities. 
    • Multiple Formats - Complies with eCTD, NeeS, and RPS formats when implemented.
       

    Benefits: 

    • Reduced IT Overhead - Cloud-powered, platform and browser agnostic web-hosted technology does not require any installations.
    • Training - Training provided by submissions experts.
    • Access - Anytime, anywhere access via PC or MAC with an internet connection.
    • Continuous Delivery - Continuous delivery and enhancements without manual upgrades.
    • Search - Search across and within submission applications, leafs, and documents.
    • Interoperability - Interoperable with the entire Synchrogenix Ecosystem, including all of Synchrogenix’s GlobalSubmit eCTD publishing and validation solutions, GlobalSubmit RIM system, and other life-science solutions.