Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • RegDesk Reviews & Ratings
    19 Ratings
    Company Website
  • XpertCoding Reviews & Ratings
    42 Ratings
    Company Website
  • Predict360 Reviews & Ratings
    18 Ratings
    Company Website
  • Jotform Reviews & Ratings
    8,206 Ratings
    Company Website
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    66 Ratings
    Company Website
  • Passwork Reviews & Ratings
    99 Ratings
    Company Website
  • SDS Manager Reviews & Ratings
    4 Ratings
    Company Website
  • Proton Drive Reviews & Ratings
    3,602 Ratings
    Company Website
  • Captain Compliance Reviews & Ratings
    200 Ratings
    Company Website
  • Qualio Reviews & Ratings
    858 Ratings
    Company Website

What is GlobalSubmit?

Whether you are an experienced expert or just starting out in the realm of regulatory submissions, the threat of rejection for your electronic common technical document (eCTD) submissions is a pressing issue, especially given the growing complexity and continual changes in the regulatory environment. Additionally, the differences in eCTD submission standards across various regions, coupled with the difficulties of overseeing the entire document lifecycle, can hinder your organization’s goals of expediting market access. By leveraging Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will gain access to essential resources for effectively publishing, validating, and reviewing eCTD submissions. This method not only helps reduce risks but also allows for a more straightforward eCTD submission workflow, which in turn enables your regulatory team to meet crucial deadlines and deliver treatments to patients efficiently. As your regulatory department continues to work hard under pressure to meet strict timelines and facilitate patient access to innovative therapies, the task of filing eCTD submissions becomes increasingly critical. Thus, it is vital to have appropriate tools and support in place to enhance your submission efficiency, significantly improving your chances of success and ultimately benefiting patient care. Moreover, investing in advanced submission management solutions can lead to smoother operations and better alignment with regulatory demands.

What is Essenvia?

Essenvia significantly boosts corporate value and enhances operational productivity across multiple teams and departments. Functioning as a centralized repository for all regulatory information, it streamlines collaborative document generation and reporting, while also mitigating risks related to technical holds, RTAs, and RFIs. This innovative platform equips regulatory affairs teams with the tools necessary to expedite product launches, thereby preventing potential revenue losses stemming from delays in submissions and overlooked renewals. Offering a detailed perspective of the complete regulatory lifecycle, Essenvia features executive dashboards, key performance indicators, and timely alerts for global registrations, submissions, and modifications. Acting as a Regulatory Information Management (RIM) platform, it optimizes regulatory workflows throughout the product lifecycle, enabling quicker access to global markets and providing substantial competitive advantages. By unifying all regulatory processes into a single platform, businesses can significantly accelerate their entry into the market. Moreover, it contains a centralized archive for all registration documents, which are seamlessly tied to product master data, empowering users to efficiently oversee the product registration lifecycle on a country-specific basis while ensuring compliance and operational excellence. This holistic approach not only enhances efficiency but also fosters better collaboration among teams.

Media

Media

Integrations Supported

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

Integrations Supported

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Certara

Date Founded

2008

Company Location

United States

Company Website

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

Company Facts

Organization Name

Essenvia

Company Location

United States

Company Website

essenvia.com

Categories and Features

Categories and Features

Popular Alternatives

BeeCTD Reviews & Ratings

BeeCTD

Altamira

Popular Alternatives

LifeSphere RIMS Reviews & Ratings

LifeSphere RIMS

ArisGlobal
ProcEdge RIMS Reviews & Ratings

ProcEdge RIMS

Sarjen Systems Pvt Ltd
LICENSALE Reviews & Ratings

LICENSALE

Arazy Group
Rimsys Reviews & Ratings

Rimsys

Rimsys Regulatory Management Software