11 Regulatory Information Management Software

Demand for regulatory information management software is growing due to increasing compliance requirements from health authorities, such as XEVMPD, IDMP, UDI and others; as well as growing product / market portfolio of companies to ensure seamless management of regulatory information.


ROS has researched a list of regulatory information management software available in market today.


1. ViSU™ (By DDi Technology)- ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control.

2. RIMS Rx Software (By Master Control)- MasterControl’s regulatory information management (RIM) system software keeps your product reviews, approval and release on track and ahead of your competitors.

3. RIM Amplelogic (By Amplelogic)- RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.

4. Iqvia™ RIM Smart (By Iqvia)- IQVIA RIM Smart delivers fully integrated, technology-led, intelligent management of the complete regulatory lifecycle so you can focus on what you do best-getting safe, efffective products to market and keeping them there. It automates high volume tasks, boosting speed, accuracy and efficiency, lowering costs, improving data quality and enabling global visibility across the portfolio. RIM Smart is the onlu solution with an embedded regulatory information database (RID).

5. LifeSphere RIMS (By Aris Global)- LifeSphere® RIMS delivers end-to-end regulatory information management in an all-new, easy-to-use cloud application that accelerates speed to market, reduces risk and streamlines collaboration across teams.

6. Vault RIM Suite (By Veeva Vault)- The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility.

7. Freyr SPAR (By Freyr Solutions)- Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information; right from tracking product registrations, marketing authorization lifecycles, managing product data, Regulatory document management, health authority interactions and correspondence, and to generate statistical reports. With a modular, and well-structured product data driven system that is built ground up on ISO IDMP standards, Freyr SPAR – System for Products And Registrations, assists users in future IDMP submission processes.

8. Extedo Pulse (By Extedo Inc)- EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individu­ally or gain additional value by using them together based on your requirements.

9. Ennov RIM (By Ennov Solutions)- Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide.

10.Rimsys RIM (By Rimsys)- The Rimsys Regulatory Information Management Platform digitizes and automates regulatory activities in a single cloud-based platform, helping regulatory affairs teams reduce manual administrative work and confidently manage global compliance.

11.R&D Expert™ (By Amplexor)- R&DExpert™ promotes cross-functional collaboration and establishes a single authoritative document asset repository, covering all document management functionalities, including template management, workflows, advanced rendering and permissions.


Access complete report on software for regulatory, quality and safety compliance here.



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