North America Regulatory Information Management System Market Size, Share & Trends Analysis Report By End User (Pharmaceutical Sector, Medical Device Sector, and Others), By Country and Growth Forecast, 2024 - 2031

The North America Regulatory Information Management System Market would witness market growth of 9.8% CAGR during the forecast period (2024-2031).

The US market dominated the North America Regulatory Information Management System Market by Country in 2023, and would continue to be a dominant market till 2031; thereby, achieving a market value of $1,203.8 Million by 2031. The Canada market is registering a CAGR of 12.3% during (2024 - 2031). Additionally, The Mexico market would showcase a CAGR of 11.3% during (2024 - 2031).

The drug development process in the pharmaceutical sector is highly complex and involves multiple stages, including preclinical research, clinical trials, regulatory submissions, and post-market surveillance. Managing regulatory submissions, clinical trial documentation, and approvals requires coordination across cross-functional teams, adherence to regulatory guidelines, and compliance with regulatory timelines. For example, as per Invest India, the pharmaceutical industry in India is anticipated to increase to $65 billion by 2024 and $130 billion by 2030. Regulatory information management systems provide document management, submission tracking, and compliance monitoring capabilities, enabling pharmaceutical companies to streamline regulatory processes and accelerate time-to-market for new drugs.

There is a growing preference for cloud-based RIMS solutions due to their scalability, flexibility, and cost-effectiveness. Cloud-based RIMS offers easier deployment, maintenance, and accessibility, allowing companies to access regulatory data and processes from anywhere, anytime. Integration of RIMS with other enterprise systems, such as Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), and Enterprise Resource Planning (ERP) systems, is gaining traction. Seamless integration streamlines data exchange improves workflow efficiency and enhances regulatory compliance across the organization.

Mexico's pharmaceutical manufacturing business has grown significantly in recent years, owing to increased healthcare spending, rising demand for pharmaceutical products, and government attempts to encourage domestic production and innovation. According to the Mexican government, the manufacturing sector's gross domestic product was $5.18 trillion MX in the fourth quarter of 2023. The pharmaceutical manufacturing sector in Mexico is increasingly adopting technology and automation to improve operational efficiency, enhance product quality, and ensure regulatory compliance in Mexico. Automation of regulatory compliance activities accelerates the product development lifecycle and enhances regulatory efficiency in Mexico's pharmaceutical industry. Hence, the factors mentioned above will drive the regional market growth.

Free Valuable Insights: The Regulatory Information Management System Market is Predict to reach USD 4.7 Billion by 2031, at a CAGR of 10.5%

Based on End User, the market is segmented into Pharmaceutical Sector, Medical Device Sector, and Others. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.

List of Key Companies Profiled

• Veeva Systems, Inc.
• Korber AG (Optel Group)
• ArisGlobal LLC (Nordic Capital Limited)
• Calyx
• Ennov SAS
• MasterControl, Inc.
• LORENZ Life Sciences Group
• AmpleLogic
• Cencora, Inc. (PharmaLex Holding GmbH)
• Ithos Global Inc. (Cordance Group)

North America Regulatory Information Management System Market Report Segmentation

By End User

• Pharmaceutical Sector
• Medical Device Sector
• Others

By Country

• US
• Canada
• Mexico
• Rest of North America

Chapter 1. Market Scope & Methodology
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 North America Regulatory Information Management System Market, by End User
1.4.2 North America Regulatory Information Management System Market, by Country
1.5 Methodology for the research

Chapter 2. Market at a Glance
2.1 Key Highlights

Chapter 3. Market Overview
3.1 Introduction
3.1.1 Overview
3.1.1.1 Market Composition and Scenario
3.2 Key Factors Impacting the Market
3.2.1 Market Drivers
3.2.2 Market Restraints
3.2.3 Market Opportunities
3.2.4 Market Challenges
3.3 Porter’s Five Forces Analysis

Chapter 4. Strategies Deployed in Regulatory Information Management System Market

Chapter 5. North America Regulatory Information Management System Market by End User
5.1 North America Pharmaceutical Sector Market by Country
5.2 North America Medical Device Sector Market by Country
5.3 North America Others Market by Country

Chapter 6. North America Regulatory Information Management System Market by Country
6.1 US Regulatory Information Management System Market
6.1.1 US Regulatory Information Management System Market by End User
6.2 Canada Regulatory Information Management System Market
6.2.1 Canada Regulatory Information Management System Market by End User
6.3 Mexico Regulatory Information Management System Market
6.3.1 Mexico Regulatory Information Management System Market by End User
6.4 Rest of North America Regulatory Information Management System Market
6.4.1 Rest of North America Regulatory Information Management System Market by End User

Chapter 7. Company Profiles
7.1 Veeva Systems, Inc.
7.1.1 Company Overview
7.1.2 Financial Analysis
7.1.3 Regional Analysis
7.1.4 Research & Development Expenses
7.1.5 Recent strategies and developments:
7.1.5.1 Partnerships, Collaborations, and Agreements:
7.1.5.2 Acquisition and Mergers:
7.1.6 SWOT Analysis
7.2 Korber AG
7.2.1 Company Overview
7.2.2 Recent strategies and developments:
7.2.2.1 Partnerships, Collaborations, and Agreements:
7.2.2.2 Acquisition and Mergers:
7.2.3 SWOT Analysis
7.3 ArisGlobal LLC (Nordic Capital Limited)
7.3.1 Company Overview
7.3.2 Recent strategies and developments:
7.3.2.1 Product Launches and Product Expansions:
7.3.2.2 Acquisition and Mergers:
7.3.3 SWOT Analysis
7.4 Calyx
7.4.1 Company Overview
7.4.2 SWOT Analysis
7.5 Ennov SAS
7.5.1 Company Overview
7.5.2 Recent strategies and developments:
7.5.2.1 Acquisition and Mergers:
7.5.3 SWOT Analysis
7.6 MasterControl, Inc.
7.6.1 Company Overview
7.6.2 SWOT Analysis
7.7 LORENZ Life Sciences Group
7.7.1 Company Overview
7.7.2 Recent strategies and developments:
7.7.2.1 Partnerships, Collaborations, and Agreements:
7.7.3 SWOT Analysis
7.8 AmpleLogic
7.8.1 Company Overview
7.8.2 SWOT Analysis
7.9 Cencora, Inc. (PharmaLex Holding GmbH)
7.9.1 Company Overview
7.9.2 Financial Analysis
7.9.3 Segmental Analysis
7.9.4 SWOT Analysis
7.10. Ithos Global Inc. (Cordance Group)
7.10.1 Company Overview
7.10.2 SWOT Analysis

TABLE 1 North America Regulatory Information Management System Market, 2020 - 2023, USD Million
TABLE 2 North America Regulatory Information Management System Market, 2024 - 2031, USD Million
TABLE 3 North America Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
TABLE 4 North America Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
TABLE 5 North America Pharmaceutical Sector Market by Country, 2020 - 2023, USD Million
TABLE 6 North America Pharmaceutical Sector Market by Country, 2024 - 2031, USD Million
TABLE 7 North America Medical Device Sector Market by Country, 2020 - 2023, USD Million
TABLE 8 North America Medical Device Sector Market by Country, 2024 - 2031, USD Million
TABLE 9 North America Others Market by Country, 2020 - 2023, USD Million
TABLE 10 North America Others Market by Country, 2024 - 2031, USD Million
TABLE 11 North America Regulatory Information Management System Market by Country, 2020 - 2023, USD Million
TABLE 12 North America Regulatory Information Management System Market by Country, 2024 - 2031, USD Million
TABLE 13 US Regulatory Information Management System Market, 2020 - 2023, USD Million
TABLE 14 US Regulatory Information Management System Market, 2024 - 2031, USD Million
TABLE 15 US Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
TABLE 16 US Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
TABLE 17 Canada Regulatory Information Management System Market, 2020 - 2023, USD Million
TABLE 18 Canada Regulatory Information Management System Market, 2024 - 2031, USD Million
TABLE 19 Canada Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
TABLE 20 Canada Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
TABLE 21 Mexico Regulatory Information Management System Market, 2020 - 2023, USD Million
TABLE 22 Mexico Regulatory Information Management System Market, 2024 - 2031, USD Million
TABLE 23 Mexico Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
TABLE 24 Mexico Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
TABLE 25 Rest of North America Regulatory Information Management System Market, 2020 - 2023, USD Million
TABLE 26 Rest of North America Regulatory Information Management System Market, 2024 - 2031, USD Million
TABLE 27 Rest of North America Regulatory Information Management System Market by End User, 2020 - 2023, USD Million
TABLE 28 Rest of North America Regulatory Information Management System Market by End User, 2024 - 2031, USD Million
TABLE 29 Key Information – Veeva Systems, Inc.
TABLE 30 Key Information – Korber AG
TABLE 31 Key Information – ArisGlobal LLC
TABLE 32 Key Information – Calyx
TABLE 33 Key Information – Ennov SAS
TABLE 34 key information – MasterControl, Inc.
TABLE 35 Key Information – LORENZ Life Sciences Group
TABLE 36 Key Information – AmpleLogic
TABLE 37 Key Information – Cencora, Inc.
TABLE 38 Key Information – Ithos Global Inc.

List of Figures
FIG 1 Methodology for the research
FIG 2 North America Regulatory Information Management System Market, 2020 - 2031, USD Million
FIG 3 Key Factors Impacting Regulatory Information Management System Market
FIG 4 Porter’s Five Forces Analysis – Regulatory Information Management System Market
FIG 5 North America Regulatory Information Management System Market share by End User, 2023
FIG 6 North America Regulatory Information Management System Market share by End User, 2031
FIG 7 North America Regulatory Information Management System Market by End User, 2020 - 2031, USD Million
FIG 8 North America Regulatory Information Management System Market share by Country, 2023
FIG 9 North America Regulatory Information Management System Market share by Country, 2031
FIG 10 North America Regulatory Information Management System Market by Country, 2020 - 2031, USD Million
FIG 11 Recent strategies and developments: Veeva Systems, Inc.
FIG 12 Swot Analysis: Veeva Systems, Inc.
FIG 13 Swot Analysis: Korber AG
FIG 14 Swot Analysis: ArisGlobal LLC
FIG 15 Swot Analysis: Calyx
FIG 16 Swot Analysis: Ennov SAS
FIG 17 Swot Analysis: MasterControl, Inc.
FIG 18 Swot Analysis: LORENZ Life Sciences Group
FIG 19 Swot Analysis: AmpleLogic
FIG 20 Swot Analysis: Cencora, Inc.
FIG 21 Swot Analysis: Ithos Global Inc.