GlobalSubmit

GlobalSubmit

Certara
+
+

Related Products

  • RegDesk
    19 Ratings
    Visit Website
  • LinkSquares
    713 Ratings
    Visit Website
  • Propel
    204 Ratings
    Visit Website
  • MedTrainer
    242 Ratings
    Visit Website
  • Jesta Vision Suite
    25 Ratings
    Visit Website
  • SBS Asset Finance
    3 Ratings
    Visit Website
  • Qualio
    858 Ratings
    Visit Website
  • Regpack
    387 Ratings
    Visit Website
  • Predict360
    18 Ratings
    Visit Website
  • FusionAuth
    178 Ratings
    Visit Website

About

Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country.

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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medtech companies in need of a solution to manage their regulatory workflows across the total product lifecycle

Audience

Companies seeking a solution designed to simplify complex regulatory processes

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Essenvia
United States
essenvia.com

Company Information

Certara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

Alternatives

Alternatives

BeeCTD

BeeCTD

Altamira
ProcEdge RIMS

ProcEdge RIMS

Sarjen Systems Pvt Ltd
LifeSphere RIMS

LifeSphere RIMS

ArisGlobal
LICENSALE

LICENSALE

Arazy Group
Rimsys

Rimsys

Rimsys Regulatory Management Software
Ennov Doc

Ennov Doc

Ennov

Categories

Categories

Integrations

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

Integrations

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio
Claim Essenvia and update features and information
Claim Essenvia and update features and information
Claim GlobalSubmit and update features and information
Claim GlobalSubmit and update features and information