As of August 2026, Latka tracks 5 regulatory information management systems companies. They have combined revenues of $21M and employ 186 people.
Every company below sells regulatory information management systems to other businesses and is ranked by its most recent annual revenue. Revenue, funding, headcount and customer figures come from CEO interviews on the Latka podcast, public company filings, and Latka estimates where a company has not disclosed a number.
Regulatory Information Management (RIM) Systems are centralized software platforms designed to assist organizations in managing regulatory activities efficiently. These systems serve as a 'single source of truth' for regulatory affairs teams, facilitating the storage, organization, and retrieval of regulatory documents and data. By providing a cohesive framework, RIM systems enable organizations to navigate complex regulatory landscapes effectively, ensuring compliance with ever-evolving regulations. Typical use cases for RIM systems include tracking product registrations, managing submission dossiers, and supporting compliance planning and execution. Features often found in RIM software include document management, workflow automation, and integration capabilities with other enterprise systems. Common users of RIM systems include regulatory affairs professionals, compliance officers, and product teams, primarily within industries such as pharmaceuticals, biotechnology, and medical devices. These tools streamline the regulatory process and enhance collaboration among stakeholders involved in regulatory compliance.
Sorting: Highest -> Lowest
Showing 5 of 5 companies ranked by annual revenue.
Vienna, Austria
Flinn.ai is an AI-driven platform to automate regulatory and quality processes for MedTech companies, streamlining compliance submissions and enabling manufacturers to operate more efficiently.
Givatyim, Israel
We Specialize in using Orcanos cloud software to help medical device, pharmaceutical, automotive, and aerospace manufacturers with their regulatory compliance. We have been particularly successful with manufacturers concerned about the cost of manual traceability management and were unhappy with the bottlenecks created using a paper-based quality system that slowed down the organization and put it at high risk. Our mission is to automate design control and quality management in ONE platform that adapts to the customer instead of the customer adapting to the software. By that, we reduce the overall cost and risk associated with regulatory compliance.
Sorocaba, São Paulo, Brazil
Life Sciences companies including pharmaceutical and medical devices are required by regulatory agencies such as the FDA, EMA, and WHO to validate and qualify their systems, processes, and equipment. This activity is time-consuming, bureaucratic, and done on paper. Validation is an activity that if not done successfully can impact the business by preventing it from operating. To solve this problem, FIVE developed a cloud tool that contains information (content) that allows the user to work 6x faster, in addition to protecting the environment by not using paper. FIVE's software product: - GO!FIVE paperless validation solution. FIVE provides the following professional services: - Computer System Validation - Equipment validation - Utilities qualification - IT and OT infrastructure qualification - Data integrity projects - Training and consulting
Pittsburgh, Pennsylvania, United States
Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software helps medtech regulatory affairs teams plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Unlike complex, color-coded spreadsheets, Rimsys centralizes regulatory information, automates submission processes, and provides visibility into product registrations, expirations, standards, and regulations. Rimsys supports a full breadth of regulatory activities in an integrated platform, helping medtech companies to better manage regulatory projects and resources, get products to market more quickly, and reduce risk of non-compliance, product recalls, and unexpected expirations. Request a demo at https://www.rimsys.io/demo. Contact us: [email protected]
Los Angeles, California, United States
Essenvia is a MedTech RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value.
Latka tracks 5 regulatory information management systems companies with reported revenue. Together they generate $21M in annual revenue and employ 186 people.
Flinn.ai is the largest, with $5.2M in annual revenue, founded in 2022.
The average regulatory information management systems company in this list makes $4.2M a year, across 5 companies with reported revenue.
Ranked by annual revenue, the leaders are Flinn.ai, Orcanos, FIVE Validation, Rimsys Regulatory Management Software and Essenvia.
- Product must provide centralized document management for regulatory information. - Must support the tracking and management of product registrations and submissions. - Should include features that facilitate compliance planning and documentation. - Integration capabilities with other software tools or platforms are essential. - Must cater specifically to regulatory affairs teams and their workflows. - Not just for general document management; must include regulatory-specific features.
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