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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 Kivo?
Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.
Integrations Supported
Docusign
Microsoft 365
Adobe Acrobat Sign
Amazon Web Services (AWS)
Google Workspace
Microsoft Azure
Integrations Supported
Docusign
Microsoft 365
Gmail
Jama Connect
Jira
Microsoft Excel
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Supported Platforms
SaaS
On-Prem
Supported Platforms
SaaS
Customer Service / Support
Web-Based Support
Customer Service / Support
Web-Based Support
Training Options
Not specified
Training Options
Documentation Hub
Online Training
Company Facts
Organization Name
Healthlane Technologies
Date Founded
2017
Company Location
India
Company Website
www.zelthy.com/solutions/regulatory
Company Facts
Organization Name
Kivo
Date Founded
2021
Company Location
United States
Company Website
kivo.io
Categories and Features
Regulatory Information Management (RIM)
Not specified
Categories and Features
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Print Management
Version Control
Life Sciences
Not specified
Medical Quality Management Systems
Not specified
Pharmaceutical and Biotech
Not specified
Regulatory Information Management (RIM)
Not specified