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What is Impurity Profiling Suite?

In order to comply with ICH M7 regulations, it is essential to forecast genotoxic and carcinogenic outcomes for impurities and degradation products. The Impurity Profiling Suite serves as a valuable resource in your ICH M7 process, assisting you in the preparation of regulatory documents while ensuring adherence to compliance standards. This tool not only streamlines your workflow but also enhances the accuracy of your assessments.

What is Evidex?

Efficiently monitoring a variety of data sources, in conjunction with a GVP IX compliant signal management system, can significantly enhance the way safety data is processed. The Evidex platform provides a comprehensive, ready-to-use solution that adheres to GVP-IX standards, allowing for smoother operations without the need to navigate through multiple services. By updating your management workflows, you can create processes that are both efficient and resistant to audits. This level of automation aids in fulfilling regulatory requirements while simultaneously increasing the overall benefits for your organization. Through the use of automated signal detection, safety signals can be recognized from key resources, such as ICSR databases and the FDA's Adverse Event Reporting System (FAERS), alongside VigiBase and clinical trial information. Additionally, you can enhance your data landscape by adding other sources like claims, electronic health records (EHR), and various forms of unstructured data. By combining these different data sources, you can enhance signaling algorithms, streamline validation processes, and respond more swiftly to urgent drug safety issues. Furthermore, this innovative approach redefines how organizations handle and utilize safety data, ultimately leading to improved results and a more proactive stance on drug safety management.

Media

Media

Integrations Supported

Integrations Supported

Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

Windows

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Not specified

Company Facts

Organization Name

ACD/Labs

Date Founded

1994

Company Location

Canada

Company Website

www.acdlabs.com/products/percepta-platform/impurity-profiling-suite/

Company Facts

Organization Name

Advera Health Analytics

Date Founded

2010

Company Location

United States

Company Website

www.adverahealth.com

Categories and Features

Drug Discovery

Not specified

Categories and Features

Drug Discovery

Not specified

Pharmacovigilance

Not specified

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