GlobalSubmitCertara
|
||||||
Related Products
|
||||||
About
ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices. ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in regulatory information management system (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in the management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have visibility and tracking of all regulatory information. With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations.
|
About
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 document 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. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.
|
|||||
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Healthcare organizations and companies in need of a tool to manage and track all of their regulatory data
|
Audience
Companies seeking a solution designed to simplify complex regulatory processes
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Not Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
|
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Supported
|
|||||
Company InformationClinChoice
United States
clinchoice.com/solutions/regulatory-affairs/regulatory-information-management/
|
Company InformationCertara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
|
|||||
Alternatives |
Alternatives |
|||||
|
|
|
|||||
|
|
|
|||||
|
|
|
|||||
Categories |
Categories |
|||||
Integrations
No info available.
|
Integrations
No info available.
|
|||||
|
|
|