Audience

Regulatory affairs and regulatory operations teams at pharmaceutical and biotech companies

About Zelthy Regulatory Affairs

Zelthy Regulatory Affairs is software for pharmaceutical and biotechnology regulatory teams managing submissions across health authorities and jurisdictions. It provides a consolidated view of submission pipelines, milestones, jurisdiction-specific requirements and health authority queries. Teams can organize regulatory dossiers, validate publishing packages, coordinate review, and track post-approval variations and labeling changes. Regulatory intelligence tools monitor guideline and requirement updates, assess portfolio impact and flag dossier readiness gaps. AI-assisted functions support document assembly and draft preparation for regulatory review. The platform connects with enterprise systems through documented integrations, including Veeva RIM, and is available for cloud, on-premises or hybrid deployment.

Integrations

API:
Yes, Zelthy Regulatory Affairs offers API access
See Integrations

Ratings/Reviews

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Company Information

Healthlane Technologies
Founded: 2017
India
www.zelthy.com/solutions/regulatory

Videos and Screen Captures

Regulatory document pipeline diagram with AI drafting, review-cycle comparison, and outcome metrics.

Regulatory document pipeline diagram with AI drafting, review-cycle comparison, and outcome metrics.

Regulatory document pipeline diagram with AI drafting, review-cycle comparison, and outcome metrics.
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Product Details

Platforms Supported
Cloud
On-Premises
Support
Online

Zelthy Regulatory Affairs Frequently Asked Questions

Q: What kinds of users and organization types does Zelthy Regulatory Affairs work with?
Zelthy Regulatory Affairs works with these users and organization types: Mid Size Business, Small Business, Enterprise, Freelance, Nonprofit, Government, and Startup.
Q: What languages does Zelthy Regulatory Affairs support in their product?
Zelthy Regulatory Affairs supports these languages: English.
Q: What kind of support options does Zelthy Regulatory Affairs offer?
Zelthy Regulatory Affairs offers support via online.
Q: What other applications or services does Zelthy Regulatory Affairs integrate with?
Zelthy Regulatory Affairs integrates with: Adobe Acrobat Sign, Amazon Web Services (AWS), Microsoft Azure, Docusign, Google Workspace, NiCE CXone Mpower, Microsoft 365, Salesforce, Snowflake, TraceLink, Twilio, Veeva CRM, Veeva Vault RIM, Veeva Vault, and Zelthy Platform.
Q: Does Zelthy Regulatory Affairs have an API?
Yes, Zelthy Regulatory Affairs has an API.

Zelthy Regulatory Affairs Product Features