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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 Samarind RMS?

Samarind RMS presents an advanced approach to managing your medical product information with greater efficiency. By utilizing Samarind RMS, users can enter data a single time and leverage it multiple times as necessary. For example, an 'INN' can be recorded once and subsequently used for all relevant IMA submissions, renewals, variations, PSURs, and XEVMPD processes. This concept applies to all critical data within the system, which has proven to boost workflow efficiency and enhance data quality significantly. Our user-friendly approach to system design and execution enables clients to manage their licenses effortlessly and with assurance, as our single-source-of-truthâ„¢ method for regulatory affairs professionals delivers a thorough end-to-end solution. Furthermore, our platform features an electronic document management system (EDMS) that includes version control, template creation, and the ability to integrate with external document management solutions like Documentumâ„¢ or SharePointâ„¢, facilitating a smooth incorporation of all your documentation requirements. Ultimately, Samarind RMS not only enables users to handle their information effectively but also fosters improved collaboration among various departments, thereby enhancing overall operational productivity. This comprehensive capability makes it a valuable asset for any organization in the medical field.

Media

Media

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

Microsoft SharePoint
OpenText Documentum

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

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Healthlane Technologies

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/regulatory

Company Facts

Organization Name

Instem

Date Founded

1969

Company Location

United States

Company Website

www.instem.com/solutions/samarind-rms/

Categories and Features

Categories and Features

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