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AI in Regulatory Affairs Market Size & Outlook, 2026-2034

AI in Regulatory Affairs Market Size, Share & Trends Analysis Report By Component (Software/Platform, Services), By Deployment Mode (Cloud-based, On-Premises), By Application (Regulatory Intelligence, Data Migration & Integration, Dossier Management, Document Management, Product Registration & Approvals, Pharmacovigilance & Safety Reporting, Regulatory Submissions & Publishing, Others), By End Use (Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, CRO/CDMO, Others) and By Region (North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2026-2034

Report Code: SRHI58092DR
Last Updated: Feb, 2026
Pages: 150
Author: Dhanashri Bhapakar
Format: PDF, Excel

Table Of Content

  1. Executive Summary

    1. Research Objectives
    2. Limitations & Assumptions
    3. Market Scope & Segmentation
    4. Currency & Pricing Considered
    1. Emerging Regions / Countries
    2. Emerging Companies
    3. Emerging Applications / End Use
    1. Drivers
    2. Market Warning Factors
    3. Latest Macro Economic Indicators
    4. Geopolitical Impact
    5. Technology Factors
    1. Porters Five Forces Analysis
    2. Value Chain Analysis
    1. North America
    2. Europe
    3. APAC
    4. Middle East and Africa
    5. LATAM
  2. ESG Trends

    1. Global AI in Regulatory Affairs Market Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    1. Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    6. U.S.
      1. By Component
        1. Introduction
          1. Component By Value
        2. Software/Platform
          1. By Value
        3. Services
          1. By Value
      2. By Deployment Mode
        1. Introduction
          1. Deployment Mode By Value
        2. Cloud-based
          1. By Value
        3. On-Premises
          1. By Value
      3. By Application
        1. Introduction
          1. Application By Value
        2. Regulatory Intelligence
          1. By Value
        3. Data Migration & Integration
          1. By Value
        4. Dossier Management
          1. By Value
        5. Document Management
          1. By Value
        6. Product Registration & Approvals
          1. By Value
        7. Pharmacovigilance & Safety Reporting
          1. By Value
        8. Regulatory Submissions & Publishing
          1. By Value
        9. Others
          1. By Value
      4. By End Use
        1. Introduction
          1. End Use By Value
        2. Pharmaceutical Companies
          1. By Value
        3. Biotechnology Companies
          1. By Value
        4. Medical Device Companies
          1. By Value
        5. CRO/CDMO
          1. By Value
        6. Others
          1. By Value
    7. Canada
    1. Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    6. U.K.
      1. By Component
        1. Introduction
          1. Component By Value
        2. Software/Platform
          1. By Value
        3. Services
          1. By Value
      2. By Deployment Mode
        1. Introduction
          1. Deployment Mode By Value
        2. Cloud-based
          1. By Value
        3. On-Premises
          1. By Value
      3. By Application
        1. Introduction
          1. Application By Value
        2. Regulatory Intelligence
          1. By Value
        3. Data Migration & Integration
          1. By Value
        4. Dossier Management
          1. By Value
        5. Document Management
          1. By Value
        6. Product Registration & Approvals
          1. By Value
        7. Pharmacovigilance & Safety Reporting
          1. By Value
        8. Regulatory Submissions & Publishing
          1. By Value
        9. Others
          1. By Value
      4. By End Use
        1. Introduction
          1. End Use By Value
        2. Pharmaceutical Companies
          1. By Value
        3. Biotechnology Companies
          1. By Value
        4. Medical Device Companies
          1. By Value
        5. CRO/CDMO
          1. By Value
        6. Others
          1. By Value
    7. Germany
    8. France
    9. Spain
    10. Italy
    11. Russia
    12. Nordic
    13. Benelux
    14. Rest of Europe
    1. Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    6. China
      1. By Component
        1. Introduction
          1. Component By Value
        2. Software/Platform
          1. By Value
        3. Services
          1. By Value
      2. By Deployment Mode
        1. Introduction
          1. Deployment Mode By Value
        2. Cloud-based
          1. By Value
        3. On-Premises
          1. By Value
      3. By Application
        1. Introduction
          1. Application By Value
        2. Regulatory Intelligence
          1. By Value
        3. Data Migration & Integration
          1. By Value
        4. Dossier Management
          1. By Value
        5. Document Management
          1. By Value
        6. Product Registration & Approvals
          1. By Value
        7. Pharmacovigilance & Safety Reporting
          1. By Value
        8. Regulatory Submissions & Publishing
          1. By Value
        9. Others
          1. By Value
      4. By End Use
        1. Introduction
          1. End Use By Value
        2. Pharmaceutical Companies
          1. By Value
        3. Biotechnology Companies
          1. By Value
        4. Medical Device Companies
          1. By Value
        5. CRO/CDMO
          1. By Value
        6. Others
          1. By Value
    7. Korea
    8. Japan
    9. India
    10. Australia
    11. Taiwan
    12. South East Asia
    13. Rest of Asia-Pacific
    1. Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    6. UAE
      1. By Component
        1. Introduction
          1. Component By Value
        2. Software/Platform
          1. By Value
        3. Services
          1. By Value
      2. By Deployment Mode
        1. Introduction
          1. Deployment Mode By Value
        2. Cloud-based
          1. By Value
        3. On-Premises
          1. By Value
      3. By Application
        1. Introduction
          1. Application By Value
        2. Regulatory Intelligence
          1. By Value
        3. Data Migration & Integration
          1. By Value
        4. Dossier Management
          1. By Value
        5. Document Management
          1. By Value
        6. Product Registration & Approvals
          1. By Value
        7. Pharmacovigilance & Safety Reporting
          1. By Value
        8. Regulatory Submissions & Publishing
          1. By Value
        9. Others
          1. By Value
      4. By End Use
        1. Introduction
          1. End Use By Value
        2. Pharmaceutical Companies
          1. By Value
        3. Biotechnology Companies
          1. By Value
        4. Medical Device Companies
          1. By Value
        5. CRO/CDMO
          1. By Value
        6. Others
          1. By Value
    7. Turkey
    8. Saudi Arabia
    9. South Africa
    10. Egypt
    11. Nigeria
    12. Rest of MEA
    1. Introduction
    2. By Component
      1. Introduction
        1. Component By Value
      2. Software/Platform
        1. By Value
      3. Services
        1. By Value
    3. By Deployment Mode
      1. Introduction
        1. Deployment Mode By Value
      2. Cloud-based
        1. By Value
      3. On-Premises
        1. By Value
    4. By Application
      1. Introduction
        1. Application By Value
      2. Regulatory Intelligence
        1. By Value
      3. Data Migration & Integration
        1. By Value
      4. Dossier Management
        1. By Value
      5. Document Management
        1. By Value
      6. Product Registration & Approvals
        1. By Value
      7. Pharmacovigilance & Safety Reporting
        1. By Value
      8. Regulatory Submissions & Publishing
        1. By Value
      9. Others
        1. By Value
    5. By End Use
      1. Introduction
        1. End Use By Value
      2. Pharmaceutical Companies
        1. By Value
      3. Biotechnology Companies
        1. By Value
      4. Medical Device Companies
        1. By Value
      5. CRO/CDMO
        1. By Value
      6. Others
        1. By Value
    6. Brazil
      1. By Component
        1. Introduction
          1. Component By Value
        2. Software/Platform
          1. By Value
        3. Services
          1. By Value
      2. By Deployment Mode
        1. Introduction
          1. Deployment Mode By Value
        2. Cloud-based
          1. By Value
        3. On-Premises
          1. By Value
      3. By Application
        1. Introduction
          1. Application By Value
        2. Regulatory Intelligence
          1. By Value
        3. Data Migration & Integration
          1. By Value
        4. Dossier Management
          1. By Value
        5. Document Management
          1. By Value
        6. Product Registration & Approvals
          1. By Value
        7. Pharmacovigilance & Safety Reporting
          1. By Value
        8. Regulatory Submissions & Publishing
          1. By Value
        9. Others
          1. By Value
      4. By End Use
        1. Introduction
          1. End Use By Value
        2. Pharmaceutical Companies
          1. By Value
        3. Biotechnology Companies
          1. By Value
        4. Medical Device Companies
          1. By Value
        5. CRO/CDMO
          1. By Value
        6. Others
          1. By Value
    7. Mexico
    8. Argentina
    9. Chile
    10. Colombia
    11. Rest of LATAM
    1. AI in Regulatory Affairs Market Share By Players
    2. M&A Agreements & Collaboration Analysis
    1. IQVIA
      1. Overview
      2. Business Information
      3. Revenue
      4. ASP
      5. SWOT Analysis
      6. Recent Developments
    2. Freyr Solutions
    3. Nemko Group AS
    4. DDReg Pharma
    5. ArisGlobal
    6. RegASK
    7. IBM
    8. Oracle
    9. Microsoft
    10. Google (Alphabet)
    11. Tempus AI
    12. Accenture
    13. Wipro
    14. Zenovel
    15. EVERSANA
    16. Innoplexus
    17. Workiva
    18. ComplyAdvantage
    19. MetricStream
    20. Viz.ai
    21. Veeva Systems
    22. Clarivate
    23. RegAsk
    1. Research Data
      1. Secondary Data
        1. Major secondary sources
        2. Key data from secondary sources
      2. Primary Data
        1. Key data from primary sources
        2. Breakdown of primaries
      3. Secondary And Primary Research
        1. Key industry insights
    2. Market Size Estimation
      1. Bottom-Up Approach
      2. Top-Down Approach
      3. Market Projection
    3. Research Assumptions
      1. Assumptions
    4. Limitations
    5. Risk Assessment
    1. Discussion Guide
    2. Customization Options
    3. Related Reports
  3. Disclaimer

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