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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.

Description

Introducing a comprehensive global regulatory affairs platform, featuring registration management tools and expert support from regulatory professionals worldwide. This system is essential for initiating, renewing, modifying, or transferring market access approvals for your medical devices or IVDs. With LICENSALE®'s user-friendly interface and real-time data capabilities, you gain access to complete project management tools, infographic analytics, a seamless collaboration space, future market access strategies, and detailed reporting features. This empowers you to oversee your global medtech registration processes effectively. Regulatory specialists from Arazy Group meticulously examine your compliance documents, providing guidance in the preparation and submission of your applications, and they liaise with authorities until you secure the necessary marketing approvals. Furthermore, LICENSALE® encompasses specific submission and compliance requirements tailored to your product across over 140 countries, with dedicated regulatory experts available to assist in navigating each market's unique challenges. By leveraging this system, you can streamline your regulatory processes and enhance your overall market entry strategy.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Certara

Founded

2008

Country

United States

Website

www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

Vendor Details

Company Name

Arazy Group

Country

Canada

Website

arazygroup.com/licensale-2/

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