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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 Essenvia?
Essenvia significantly boosts corporate value and enhances operational productivity across multiple teams and departments. Functioning as a centralized repository for all regulatory information, it streamlines collaborative document generation and reporting, while also mitigating risks related to technical holds, RTAs, and RFIs. This innovative platform equips regulatory affairs teams with the tools necessary to expedite product launches, thereby preventing potential revenue losses stemming from delays in submissions and overlooked renewals. Offering a detailed perspective of the complete regulatory lifecycle, Essenvia features executive dashboards, key performance indicators, and timely alerts for global registrations, submissions, and modifications. Acting as a Regulatory Information Management (RIM) platform, it optimizes regulatory workflows throughout the product lifecycle, enabling quicker access to global markets and providing substantial competitive advantages. By unifying all regulatory processes into a single platform, businesses can significantly accelerate their entry into the market. Moreover, it contains a centralized archive for all registration documents, which are seamlessly tied to product master data, empowering users to efficiently oversee the product registration lifecycle on a country-specific basis while ensuring compliance and operational excellence. This holistic approach not only enhances efficiency but also fosters better collaboration among teams.
Integrations Supported
Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
PTC Windchill
SAP ERP
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
Documentation Hub
Webinars
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
Essenvia
Company Location
United States
Company Website
essenvia.com
Categories and Features
Regulatory Information Management (RIM)
Not specified
Regulatory Intelligence
Not specified
Categories and Features
Regulatory Information Management (RIM)
Not specified