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What is Rimsys?

Rimsys offers a comprehensive cloud-based platform specifically designed for the complete digitization and automation of regulatory processes. Tailored by regulatory affairs experts for their peers, Rimsys enables medtech companies to minimize repetitive tasks, accelerate their market entry, swiftly adapt to evolving regulations, and enhance collaboration among internal teams, partners, and affiliates. What sets Rimsys apart is its all-encompassing platform that facilitates a wide array of regulatory activities. Users can leverage regulatory intelligence along with digital templates to refine their regulatory strategies and simplify submission processes. The platform allows for the creation of compliant, submission-ready documentation and the consolidation of PDF packages for both electronic and print submissions. Moreover, it enables users to digitally gather and uphold evidence of compliance while linking to pertinent standards and receiving alerts about any changes. Rimsys ensures that users stay informed about modifications in standards, laws, regulations, and guidance documents affecting their products. Additionally, the platform offers the ability to generate self-service reports on applications, products, and countries, allowing users to track where their products can be marketed and their current registration statuses, thus further enhancing regulatory efficiency.

What is Ennov Regulatory Suite?

The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.

Media

Media

Integrations Supported

Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
PTC Windchill
SAP ERP

Integrations Supported

Ennov RIM

API Availability

API Availability

Pricing Information

We believe that truly centralized information and broad collaboration are key to efficient and effective regulatory affairs. That’s why we developed a holistic platform that organizes all of your regulatory information at the individual product level and a pricing model that isn’t tied to individual user seats.

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Online Training
On-Site Training

Company Facts

Organization Name

Rimsys Regulatory Management Software

Date Founded

2017

Company Location

United States

Company Website

www.rimsys.io/products/rimsys-platform

Company Facts

Organization Name

Ennov

Date Founded

1999

Company Location

France

Company Website

en.ennov.com

Categories and Features

Categories and Features

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Version Control
Workflow / Process Automation

Life Sciences

Not specified

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