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Best Regulatory Information Management (RIM) Systems

Emma Stein
ES
Researched and written by Emma Stein

Regulatory information management (RIM) systems provide a centralized record of regulatory documents and activities throughout the product development lifecycle for pharmaceutical and medtech companies. Regulatory affairs (RA) professionals rely on these systems to maintain up-to-date information for each product and ensure it meets all regional regulatory requirements to obtain market clearance and conduct post-market surveillance. RIM systems enable collaborative authoring on supporting documentation pertaining to regulatory submissions, product registration, unique device identifier (UDI) labels, essential principles, and standards management. They also provide high-level visibility into every step of the pre-to-post-market lifecycle, streamlining the auditing process. Once a product is in the post-market stage, RA teams use RIM systems to collect important product data around safety and performance and take any necessary actions.

RIM systems connect information from multiple systems, such as medical quality management systems (QMS), and create a centralized location to track product registration status, collaborate on regulatory submission documents, and improve project management workflows. Some RIM systems may offer regulatory intelligence support, allowing RA teams to monitor changes in standards and regulations and proactively accommodate those changes before they impact the selling status of products.

To qualify for inclusion in the Regulatory Information Management (RIM) Systems category, a product must:

Track detailed product information and regulatory documentation for each product
Provide regulatory document authoring tools and monitor dossier submission pipelines
Provide project management features and visibility into tasks, requests, and approvals around regulatory activities
Support post-market surveillance activities, such as feedback
Integrate with QMS and PLM solutions to support data centralization
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Best Regulatory Information Management (RIM) Systems At A Glance

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G2 takes pride in showing unbiased reviews on user satisfaction in our ratings and reports. We do not allow paid placements in any of our ratings, rankings, or reports. Learn about our scoring methodologies.

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41 Listings in Regulatory Information Management (RIM) Systems Available
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  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Rimsys is a specialized Regulatory Information Management (RIM) software solution designed specifically for MedTech manufacturers, addressing the unique regulatory challenges faced by this industry. U

    Users
    No information available
    Industries
    • Medical Devices
    Market Segment
    • 46% Mid-Market
    • 38% Enterprise
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    RIMSYS
    Company Website
    Year Founded
    2017
    HQ Location
    Pittsburgh, US
    LinkedIn® Page
    www.linkedin.com
    32 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Rimsys is a specialized Regulatory Information Management (RIM) software solution designed specifically for MedTech manufacturers, addressing the unique regulatory challenges faced by this industry. U

Users
No information available
Industries
  • Medical Devices
Market Segment
  • 46% Mid-Market
  • 38% Enterprise
Seller Details
Seller
RIMSYS
Company Website
Year Founded
2017
HQ Location
Pittsburgh, US
LinkedIn® Page
www.linkedin.com
32 employees on LinkedIn®
(17)5.0 out of 5
1st Easiest To Use in Regulatory Information Management (RIM) Systems software
Save to My Lists
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Kivo is the easiest-to-use compliant document and project management solution for Life Science companies, including Sponsors, CROs, Consultants, and Service Providers. Kivo's platform includes DMS, RI

    Users
    No information available
    Industries
    • Biotechnology
    • Pharmaceuticals
    Market Segment
    • 71% Small-Business
    • 29% Mid-Market
  • Pros and Cons
    Expand/Collapse Pros and Cons
  • Kivo Pros and Cons
    How are these determined?Information
    Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
    Pros
    Ease of Use
    9
    User Interface
    6
    Customer Support
    5
    Customization
    5
    Implementation Ease
    5
    Cons
    Learning Curve
    1
    UX Improvement
    1
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    Kivo
    Year Founded
    2021
    HQ Location
    Portland, US
    LinkedIn® Page
    www.linkedin.com
    37 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Kivo is the easiest-to-use compliant document and project management solution for Life Science companies, including Sponsors, CROs, Consultants, and Service Providers. Kivo's platform includes DMS, RI

Users
No information available
Industries
  • Biotechnology
  • Pharmaceuticals
Market Segment
  • 71% Small-Business
  • 29% Mid-Market
Kivo Pros and Cons
How are these determined?Information
Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
Pros
Ease of Use
9
User Interface
6
Customer Support
5
Customization
5
Implementation Ease
5
Cons
Learning Curve
1
UX Improvement
1
Seller Details
Seller
Kivo
Year Founded
2021
HQ Location
Portland, US
LinkedIn® Page
www.linkedin.com
37 employees on LinkedIn®

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  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    The Vault RIM Suite provides fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform including submission document management, product registration manag

    Users
    No information available
    Industries
    • Pharmaceuticals
    Market Segment
    • 60% Enterprise
    • 40% Mid-Market
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    Veeva
    Year Founded
    2007
    HQ Location
    Pleasanton, CA
    Twitter
    @veevasystems
    6,137 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    9,109 employees on LinkedIn®
    Ownership
    NYSE: VEEV
Product Description
How are these determined?Information
This description is provided by the seller.

The Vault RIM Suite provides fully integrated regulatory information management (RIM) capabilities on a single cloud-based platform including submission document management, product registration manag

Users
No information available
Industries
  • Pharmaceuticals
Market Segment
  • 60% Enterprise
  • 40% Mid-Market
Seller Details
Seller
Veeva
Year Founded
2007
HQ Location
Pleasanton, CA
Twitter
@veevasystems
6,137 Twitter followers
LinkedIn® Page
www.linkedin.com
9,109 employees on LinkedIn®
Ownership
NYSE: VEEV
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    ResearchManager Clinical Research Suite Clinical Data Management: •EDC (Electronic Data Capture) •ePRO (electronic Patient-Reported Outcomes) •RTSM (Randomization and Trial Supply Management) •

    Users
    • PhD student
    • Researcher
    Industries
    • Hospital & Health Care
    • Research
    Market Segment
    • 55% Enterprise
    • 33% Small-Business
  • Pros and Cons
    Expand/Collapse Pros and Cons
  • Clinical Research Suite Pros and Cons
    How are these determined?Information
    Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
    Pros
    Ease of Use
    79
    Interface Clarity
    18
    User Interface
    18
    Features
    17
    Data Management
    14
    Cons
    Poor Navigation
    24
    Missing Features
    15
    Difficulty
    14
    Slow Performance
    10
    Data Management Issues
    8
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Year Founded
    2013
    HQ Location
    Deventer, Overijssel
    Twitter
    @RESEARCH_MGR
    96 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    15 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

ResearchManager Clinical Research Suite Clinical Data Management: •EDC (Electronic Data Capture) •ePRO (electronic Patient-Reported Outcomes) •RTSM (Randomization and Trial Supply Management) •

Users
  • PhD student
  • Researcher
Industries
  • Hospital & Health Care
  • Research
Market Segment
  • 55% Enterprise
  • 33% Small-Business
Clinical Research Suite Pros and Cons
How are these determined?Information
Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
Pros
Ease of Use
79
Interface Clarity
18
User Interface
18
Features
17
Data Management
14
Cons
Poor Navigation
24
Missing Features
15
Difficulty
14
Slow Performance
10
Data Management Issues
8
Seller Details
Year Founded
2013
HQ Location
Deventer, Overijssel
Twitter
@RESEARCH_MGR
96 Twitter followers
LinkedIn® Page
www.linkedin.com
15 employees on LinkedIn®
Entry Level Price:Contact Us
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    MasterControl Quality Excellence is the #1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event managem

    Users
    • Quality Assurance Specialist
    • Quality Engineer
    Industries
    • Pharmaceuticals
    • Medical Devices
    Market Segment
    • 65% Mid-Market
    • 26% Enterprise
  • Pros and Cons
    Expand/Collapse Pros and Cons
  • MasterControl Quality Management System Pros and Cons
    How are these determined?Information
    Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
    Pros
    Ease of Use
    128
    Document Management
    93
    Training
    70
    Document Control
    47
    Intuitive
    45
    Cons
    Learning Curve
    45
    Not Intuitive
    45
    Difficult Usability
    36
    Feature Limitations
    33
    Complex Setup
    31
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Company Website
    Year Founded
    1993
    HQ Location
    Salt Lake City, UT
    Twitter
    @MCMasterControl
    6,305 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    796 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

MasterControl Quality Excellence is the #1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event managem

Users
  • Quality Assurance Specialist
  • Quality Engineer
Industries
  • Pharmaceuticals
  • Medical Devices
Market Segment
  • 65% Mid-Market
  • 26% Enterprise
MasterControl Quality Management System Pros and Cons
How are these determined?Information
Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
Pros
Ease of Use
128
Document Management
93
Training
70
Document Control
47
Intuitive
45
Cons
Learning Curve
45
Not Intuitive
45
Difficult Usability
36
Feature Limitations
33
Complex Setup
31
Seller Details
Company Website
Year Founded
1993
HQ Location
Salt Lake City, UT
Twitter
@MCMasterControl
6,305 Twitter followers
LinkedIn® Page
www.linkedin.com
796 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    RegDesk is an AI-powered Regulatory Information Management (RIM) platform that helps medical device companies streamline global compliance and accelerate market access. By centralizing data, automatin

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 86% Enterprise
    • 14% Mid-Market
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    RegDesk
    Year Founded
    2014
    HQ Location
    Houston, Texas, United States
    Twitter
    @RegDesk
    327 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    71 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

RegDesk is an AI-powered Regulatory Information Management (RIM) platform that helps medical device companies streamline global compliance and accelerate market access. By centralizing data, automatin

Users
No information available
Industries
No information available
Market Segment
  • 86% Enterprise
  • 14% Mid-Market
Seller Details
Seller
RegDesk
Year Founded
2014
HQ Location
Houston, Texas, United States
Twitter
@RegDesk
327 Twitter followers
LinkedIn® Page
www.linkedin.com
71 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    AmpleLogic's RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submissi

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 100% Mid-Market
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Year Founded
    2010
    HQ Location
    Hyderabad, Telangana
    Twitter
    @Ample_Logic
    647 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    313 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

AmpleLogic's RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submissi

Users
No information available
Industries
No information available
Market Segment
  • 100% Mid-Market
Seller Details
Year Founded
2010
HQ Location
Hyderabad, Telangana
Twitter
@Ample_Logic
647 Twitter followers
LinkedIn® Page
www.linkedin.com
313 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Validfor is a digital validation lifecycle management platform that modernizes how regulated organizations manage their computerized system validations. Designed for the life sciences, pharmaceutical,

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 50% Small-Business
    • 50% Mid-Market
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    Validfor
    Year Founded
    2024
    HQ Location
    N/A
    LinkedIn® Page
    www.linkedin.com
    5 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Validfor is a digital validation lifecycle management platform that modernizes how regulated organizations manage their computerized system validations. Designed for the life sciences, pharmaceutical,

Users
No information available
Industries
No information available
Market Segment
  • 50% Small-Business
  • 50% Mid-Market
Seller Details
Seller
Validfor
Year Founded
2024
HQ Location
N/A
LinkedIn® Page
www.linkedin.com
5 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    CARA removes the technological and financial drawbacks of a network of individual systems – instead, you can consolidate complex regulated business processes, data and content onto a single, unified p

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 100% Enterprise
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Year Founded
    1997
    HQ Location
    London, England, United Kingdom
    Twitter
    @Generis_Cara
    96 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    87 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

CARA removes the technological and financial drawbacks of a network of individual systems – instead, you can consolidate complex regulated business processes, data and content onto a single, unified p

Users
No information available
Industries
No information available
Market Segment
  • 100% Enterprise
Seller Details
Year Founded
1997
HQ Location
London, England, United Kingdom
Twitter
@Generis_Cara
96 Twitter followers
LinkedIn® Page
www.linkedin.com
87 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Essenvia is an online platform to streamline regulatory pathway for medical device companies. FDA research data indicates that regulatory submissions have grown in complexity and size with an average

    We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
    Industries
    No information available
    Market Segment
    No information available
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    Essenvia
    Year Founded
    2018
    HQ Location
    Los Angeles, US
    LinkedIn® Page
    www.linkedin.com
    23 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Essenvia is an online platform to streamline regulatory pathway for medical device companies. FDA research data indicates that regulatory submissions have grown in complexity and size with an average

We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
Industries
No information available
Market Segment
No information available
Seller Details
Seller
Essenvia
Year Founded
2018
HQ Location
Los Angeles, US
LinkedIn® Page
www.linkedin.com
23 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Sarjen's PvEdge Automation is a highly capable and globally compliant pharmacovigilance solution designed to streamline and automate critical safety processes for a wide range of products, including d

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 100% Enterprise
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Year Founded
    1998
    HQ Location
    N/A
    LinkedIn® Page
    www.linkedin.com
    348 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Sarjen's PvEdge Automation is a highly capable and globally compliant pharmacovigilance solution designed to streamline and automate critical safety processes for a wide range of products, including d

Users
No information available
Industries
No information available
Market Segment
  • 100% Enterprise
Seller Details
Year Founded
1998
HQ Location
N/A
LinkedIn® Page
www.linkedin.com
348 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    ViSU is a Cloud based Centralized Regulatory Information Management (RIM) solution to efficiently manage your regulatory data, activities, processes, submissions and commitments.

    Users
    No information available
    Industries
    No information available
    Market Segment
    • 100% Mid-Market
  • Pros and Cons
    Expand/Collapse Pros and Cons
  • ViSU Pros and Cons
    How are these determined?Information
    Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
    Pros
    Automation
    1
    Efficiency Improvement
    1
    Cons
    Subscription Costs
    1
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    DDismart
    Year Founded
    1996
    HQ Location
    Princeton, US
    Twitter
    @DDiSmart
    74 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    185 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

ViSU is a Cloud based Centralized Regulatory Information Management (RIM) solution to efficiently manage your regulatory data, activities, processes, submissions and commitments.

Users
No information available
Industries
No information available
Market Segment
  • 100% Mid-Market
ViSU Pros and Cons
How are these determined?Information
Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
Pros
Automation
1
Efficiency Improvement
1
Cons
Subscription Costs
1
Seller Details
Seller
DDismart
Year Founded
1996
HQ Location
Princeton, US
Twitter
@DDiSmart
74 Twitter followers
LinkedIn® Page
www.linkedin.com
185 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    The Amplexor Regulatory Information Management (RIM Platform is a comprehensive solution designed to streamline regulatory processes within the life sciences industry. It offers a unified system that

    We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
    Industries
    No information available
    Market Segment
    No information available
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    HQ Location
    N/A
    LinkedIn® Page
    www.linkedin.com
    1 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

The Amplexor Regulatory Information Management (RIM Platform is a comprehensive solution designed to streamline regulatory processes within the life sciences industry. It offers a unified system that

We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
Industries
No information available
Market Segment
No information available
Seller Details
HQ Location
N/A
LinkedIn® Page
www.linkedin.com
1 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    Calyx RIM is a comprehensive Regulatory Information Management (RIM solution designed to streamline the regulatory processes for life sciences organizations. It facilitates efficient management of reg

    We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
    Industries
    No information available
    Market Segment
    No information available
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Seller
    Calyx
    Year Founded
    2007
    HQ Location
    Zagreb, HR
    LinkedIn® Page
    www.linkedin.com
    18 employees on LinkedIn®
Product Description
How are these determined?Information
This description is provided by the seller.

Calyx RIM is a comprehensive Regulatory Information Management (RIM solution designed to streamline the regulatory processes for life sciences organizations. It facilitates efficient management of reg

We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
Industries
No information available
Market Segment
No information available
Seller Details
Seller
Calyx
Year Founded
2007
HQ Location
Zagreb, HR
LinkedIn® Page
www.linkedin.com
18 employees on LinkedIn®
  • Overview
    Expand/Collapse Overview
  • Product Description
    How are these determined?Information
    This description is provided by the seller.

    DXC's Regulatory Information Management Platform is a comprehensive solution designed to streamline and automate regulatory affairs processes for life sciences companies. By integrating compliance com

    We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
    Industries
    No information available
    Market Segment
    No information available
  • Seller Details
    Expand/Collapse Seller Details
  • Seller Details
    Year Founded
    2017
    HQ Location
    Ashburn, Virginia
    Twitter
    @DXCTechnology
    39,183 Twitter followers
    LinkedIn® Page
    www.linkedin.com
    84,786 employees on LinkedIn®
    Ownership
    NYSE: DXC
Product Description
How are these determined?Information
This description is provided by the seller.

DXC's Regulatory Information Management Platform is a comprehensive solution designed to streamline and automate regulatory affairs processes for life sciences companies. By integrating compliance com

We don't have enough data from reviews to share who uses this product. Leave a review to contribute, or learn more about review generation.
Industries
No information available
Market Segment
No information available
Seller Details
Year Founded
2017
HQ Location
Ashburn, Virginia
Twitter
@DXCTechnology
39,183 Twitter followers
LinkedIn® Page
www.linkedin.com
84,786 employees on LinkedIn®
Ownership
NYSE: DXC