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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 Zelthy Compliance?
Zelthy Compliance is a comprehensive solution designed to monitor compliance in the pharmaceutical and life sciences industries. It efficiently integrates regulatory changes with applicable policies, procedures, programs, and accountable individuals, while AI agents diligently track business processes to identify potential risks. Teams can effectively manage the entire lifecycle of policies and standard operating procedures (SOPs), conduct thorough audits, implement necessary corrective actions, handle conflict-of-interest disclosures, authorize external activities, and manage escalations effectively. A policy-oriented assistant is on hand to offer insights related to internal procedures and escalate complex questions for more detailed evaluation. Moreover, the platform supports transparency reporting across various workflows, including the Sunshine Act, EFPIA, and Open Payments, while also ensuring compliance with OIG, OFAC, and sanctions screening. Zelthy delineates modules for GxP documentation and the stipulations of 21 CFR Part 11 audit trails. It presents a variety of integration options, such as connections to life sciences and business systems, REST APIs, SFTP, and webhooks. Specifically designed for compliance, ethics, and risk management professionals tasked with overseeing pharmaceutical operations, Zelthy Compliance provides a holistic approach to regulatory compliance. Its intuitive interface not only simplifies the navigation through complex compliance requirements but also enhances organizational efficiency and effectiveness. This makes it an invaluable resource for businesses striving to maintain the highest standards of regulatory adherence.
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Integrations Supported
Docusign
Salesforce
Snowflake
TraceLink
Veeva CRM
Veeva Vault
Zelthy Platform
Adobe Acrobat Sign
Amazon Web Services (AWS)
Integrations Supported
Docusign
Salesforce
Snowflake
TraceLink
Veeva CRM
Veeva Vault
Zelthy Platform
Cvent Event Management
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
On-Prem
Customer Service / Support
Web-Based Support
Customer Service / Support
Not specified
Training Options
Not specified
Training Options
Not specified
Company Facts
Organization Name
Healthlane Technologies
Date Founded
2017
Company Location
India
Company Website
www.zelthy.com/solutions/regulatory
Company Facts
Organization Name
Healthlane Technologies
Date Founded
2017
Company Location
India
Company Website
www.zelthy.com/solutions/compliance
Categories and Features
Regulatory Information Management (RIM)
Not specified
Categories and Features
Compliance
Not specified