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Description
ClinChoice excels in overseeing international regulatory information by leveraging advanced technology, a comprehensive grasp of both global and local regulations, and exceptional data management techniques. By harnessing its regulatory affairs and technological expertise, ClinChoice aids organizations in effectively handling their regulatory data. Our team of consultants offers essential data maintenance assistance within regulatory information management system (RIMS) software, facilitating timely application submissions, approvals, and renewals while enhancing operational efficiency and monitoring. We support the management and oversight of the drug registration process, enabling pharmaceutical and medical device manufacturers to maintain visibility and track all regulatory details. With our guidance, organizations can formulate both immediate and long-term strategies that ensure compliance with submission deadlines, all while minimizing disruption to their everyday operations, ultimately contributing to a smoother regulatory journey. This strategic partnership empowers companies to navigate the complexities of compliance with greater confidence and agility.
Description
Regardless of whether you are a seasoned professional or a newcomer to the regulatory submission landscape, the possibility of your electronic common technical document (eCTD) submissions being rejected is a significant concern, particularly in light of the increasingly intricate and evolving regulatory landscape. Furthermore, variations in eCTD submission requirements across different regions, along with the challenges of managing the entire document lifecycle, can complicate efforts to achieve your organization’s objectives for speeding up market release. By utilizing Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will be equipped with the necessary tools to efficiently publish, validate, and review eCTD submissions. This approach allows you to mitigate risks and sidestep unnecessary complexities through a streamlined eCTD submission process, ultimately supporting your regulatory team as they strive to meet critical deadlines and bring treatments to patients. Therefore, as your regulatory department works diligently to meet tight timelines and ensure timely patient access to new therapies, filing your eCTD submissions becomes an essential task. Ensure that you have the right resources in place to enhance your submission efficiency, thereby bolstering your chances for success.
API Access
Has API
API Access
Has API
Integrations
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Integrations
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Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
ClinChoice
Country
United States
Website
clinchoice.com/solutions/regulatory-affairs/regulatory-information-management/
Vendor Details
Company Name
Certara
Founded
2008
Country
United States
Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
