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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 Kalypso Accel for RIM?

Kalypso provides an economical option for life sciences companies aiming to adopt a Regulatory Information Management (RIM) system called Accel for RIM. This innovative platform supports a cohesive strategy for efficiently managing and overseeing product registrations, while also improving submission accuracy and handling global Unique Device Identification (UDI) details, which helps in optimizing product distribution. Furthermore, it integrates compliance and quality data from various enterprise systems into a single, reliable source for tracking product registrations, thus speeding up the regulatory submission process. By leveraging modern APIs, the system compiles product information along with essential regulatory documents and submission packages. Designed for quick implementation, it is based on a validated software framework that incorporates industry best practices and proven successful deployments. Companies that implement this solution can anticipate not only increased operational efficiency but also a notable decrease in the time required for regulatory activities. Additionally, this streamlined approach can significantly enhance organizational productivity and focus on strategic initiatives.

Media

Media

Integrations Supported

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

Integrations Supported

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

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Not specified

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

Kalypso

Date Founded

2004

Company Location

United States

Company Website

kalypso.com/industries/life-sciences/digital-regulatory-information-management/

Categories and Features

Categories and Features

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