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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 Valenc?

Valenc is a cloud-based platform designed specifically for chemical manufacturers to create Safety Data Sheets (SDS) and maintain chemical compliance. This cutting-edge tool allows for the importation of safety data sheets from suppliers and employs artificial intelligence to efficiently extract and organize product information while enriching records with vital chemical and regulatory details. In addition, it incorporates a deterministic GHS rules engine that classifies hazards associated with various substances with precision. For each classified product record, Valenc generates SDS sections and language variations that adhere to the regulations of specific jurisdictions, utilizing a carefully curated library of phrases. A designated review agent identifies fields that need human input, allowing selected users to meticulously review and approve each sheet before its distribution. The platform also monitors regulatory updates, quickly flagging any sheets that may be impacted, and provides options for exporting SDS alongside a REST API, which seamlessly integrates with ERP, PLM, or other custom systems. Currently, its authoring capabilities extend to regions such as the United States, Canada, Mexico, the European Union, the United Kingdom, and the UN module, supporting over 25 different languages. With its extensive features, Valenc ensures that manufacturers can efficiently manage compliance and optimize their SDS authoring process. As a result, users benefit from improved efficiency and reduced risk of non-compliance in their operations.

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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
Twilio
Veeva CRM
Veeva Vault
Veeva Vault RIM
Zelthy Platform

Integrations Supported

Model Context Protocol (MCP)

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$7,000/year
Annual software pricing starts at $7,000.
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

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

Valenc

Date Founded

2026

Company Location

United States

Company Website

www.valenc.com

Categories and Features

Categories and Features

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