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Ratings and Reviews 0 Ratings
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What is Zelthy Regulatory Affairs?
Zelthy Regulatory Affairs is an innovative software solution tailored for teams in the pharmaceutical and biotechnology industries, streamlining the management of submissions to multiple health authorities and regulatory bodies. It provides a detailed overview of submission pipelines, essential milestones, jurisdiction-specific requirements, and health authority inquiries. The platform enables teams to systematically arrange regulatory dossiers, validate publishing packages, coordinate the review process, and oversee post-approval variations and labeling changes. In addition, regulatory intelligence features are included to track updates in guidelines and requirements, assess their impact on portfolios, and uncover any gaps in dossier preparedness. Enhanced by AI capabilities, it assists in the creation of documents and the drafting of materials needed for regulatory evaluations. Moreover, Zelthy integrates seamlessly with enterprise systems like Veeva RIM and offers deployment options that include cloud, on-premises, or hybrid solutions, ensuring adaptability to meet diverse organizational needs. This all-encompassing approach not only enhances efficiency but also supports regulatory teams in maintaining compliance, making Zelthy an indispensable tool in their operational arsenal. With a focus on continuous improvement and innovation, Zelthy empowers organizations to navigate the complex regulatory landscape effectively.
What is Vistaar by DDi?
Vistaar stands out as a cutting-edge cloud-based platform tailored to meet the regulatory intelligence and compliance demands of businesses in the pharmaceutical, biotechnology, medical device, diagnostics, and consumer health industries. It features a vast and searchable collection of regulatory documents and requirements, while also monitoring changes in over 150 countries, providing timely notifications and in-depth summaries of any updates. Users can delve into regulations, guidance, and standards, assess their impacts on products and operations, assign tasks, and track obligations, deadlines, and evidence through organized workflows and compliance matrices. With the integration of AI capabilities, the platform enhances the regulatory review process with sophisticated search options, document summaries, translation services, and obligation extractions. Human-reviewed summaries are meticulously curated to ensure that users receive the most pertinent requirements for their specific needs. Furthermore, Vistaar incorporates functionalities for reporting, maintaining audit trails, and seamlessly integrating with existing electronic document management systems, regulatory information management tools, and quality management systems. This platform is expertly crafted to assist regulatory affairs, quality assurance, and compliance teams as they maneuver through the complex landscape of global life sciences regulations, proving itself to be an indispensable asset. By optimizing compliance processes, Vistaar not only streamlines operations but also allows organizations to concentrate on innovation and enhancing patient outcomes, ultimately fostering a healthier future.
Media
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Integrations Supported
Adobe Acrobat Sign
Amazon Web Services (AWS)
Docusign
Google Workspace
Microsoft 365
Microsoft Azure
NiCE CXone Mpower
Salesforce
Snowflake
TraceLink
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided
Pricing Information
Free Quick Access provides limited navigation and data-availability checks for one or two countries. The free proof-of-concept pilot provides 7 days of unlimited cloud use with full data for selected countries.
Free Trial Offered?
Supported Platforms
SaaS
On-Prem
Supported Platforms
SaaS
Customer Service / Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Not specified
Training Options
Documentation Hub
Company Facts
Organization Name
Healthlane Technologies
Date Founded
2017
Company Location
India
Company Website
www.zelthy.com/solutions/regulatory
Company Facts
Organization Name
DDi
Date Founded
2015
Company Location
United States
Company Website
www.vistaar.ai/
Categories and Features
Regulatory Information Management (RIM)
Not specified
Categories and Features
Regulatory Intelligence
Not specified