Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    4.6 out of 5 stars 66 Ratings
    Company Website for Interfacing Integrated Management System (IMS)
  • Predict360 Reviews & Ratings
    4.7 out of 5 stars 18 Ratings
    Company Website for Predict360
  • Captain Compliance Reviews & Ratings
    4.6 out of 5 stars 400 Ratings
    Company Website for Captain Compliance
  • Maintenance Care Reviews & Ratings
    4.7 out of 5 stars 298 Ratings
    Company Website for Maintenance Care
  • Qualio Reviews & Ratings
    4.4 out of 5 stars 919 Ratings
    Company Website for Qualio
  • Sovos Reviews & Ratings
    4.5 out of 5 stars 184 Ratings
    Company Website for Sovos
  • MedTrainer Reviews & Ratings
    4.3 out of 5 stars 250 Ratings
    Company Website for MedTrainer
  • Nasdaq Metrio Reviews & Ratings
    4.5 out of 5 stars 14 Ratings
    Company Website for Nasdaq Metrio
  • Passwork Reviews & Ratings
    4.7 out of 5 stars 129 Ratings
    Company Website for Passwork
  • Sumsub Reviews & Ratings
    4.6 out of 5 stars 240 Ratings
    Company Website for Sumsub

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 ProcEdge RIMS?

ProcEdge RIMS is a comprehensive regulatory information management solution crafted to help organizations effectively oversee the entire lifecycle of product registrations, from pre-approval documentation to post-registration compliance activities. Designed to replace inefficient spreadsheet tracking, the platform centralizes regulatory data and workflows, enabling seamless collaboration between departments and ensuring real-time data accuracy across global markets. It supports the management of multiple products across various countries, handling complex regulatory differences with a configurable data model and automated workflows. Key features include timeline tracking for submissions and renewals, query management to efficiently address regulatory authority questions, and electronic notifications to alert users about critical regulatory events. ProcEdge RIMS is compliant with international industry standards such as IDMP, GxP, GDPR, and 21 CFR Part 11, ensuring regulatory reliability and data security. The platform also provides audit trails and role-based access controls to maintain data integrity and compliance. By reducing manual data entry and eliminating redundant systems, it cuts operational costs and accelerates time to market. Its comprehensive tracking and reporting capabilities allow regulatory teams to plan submissions effectively and respond to regulatory inquiries promptly. With improved data control and visibility, companies gain a global view of product issues enabling quicker, informed decision-making. Ultimately, ProcEdge RIMS empowers regulatory professionals to meet complex compliance demands efficiently while driving faster product approvals and reducing risks.

Media

Media

No images available

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

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

$300

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS
Windows
On-Prem

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
24 Hour 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

Sarjen Systems Pvt Ltd

Date Founded

1998

Company Location

India

Company Website

rims.sarjen.com

Categories and Features

Categories and Features

Popular Alternatives

KnowledgeNET Reviews & Ratings

KnowledgeNET

Sarjen Systems

Popular Alternatives

LICENSALE Reviews & Ratings

LICENSALE

Arazy Group
ViSU Reviews & Ratings

ViSU

DDi