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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.

What is AmpleLogic Regulatory Information Management System?

The AmpleLogic Regulatory Information Tracker, created using a LOW CODE AND NO CODE (LCNC) PLATFORM, features two main elements: the ANDA and DMF Tracker. This software serves as a vital tool for managing pharmaceutical regulatory information, aimed at improving data accuracy, boosting operational efficiency, reducing mistakes, and promoting seamless communication across different departments. Implementing this solution enables organizations to foster enhanced collaboration while ensuring adherence to regulatory requirements. Ultimately, it supports better decision-making processes and reinforces compliance efforts within the industry.

Media

Media

No images available

Integrations Supported

AmpleLogic LCNC Platform
Arena PLM
EQMS
Oracle Product Lifecycle Management (PLM)
Qualio

Integrations Supported

AmpleLogic LCNC Platform
Arena PLM
EQMS
Oracle Product Lifecycle Management (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

Essenvia

Company Location

United States

Company Website

essenvia.com

Company Facts

Organization Name

AmpleLogic

Date Founded

2010

Company Location

India

Company Website

amplelogic.com

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