目次
						
	Table of Contents
	Chapter 1 Methodology and Scope
	
	1.1 Market Segmentation & Scope
	1.2 Information Procurement
	1.2.1 Information analysis
	1.2.2 Market formulation & data visualization
	1.2.3 Data validation & publishing
	1.3 Research Scope and Assumptions
	1.3.1 List to Data Sources
	Chapter 2 Executive Summary
	
	2.1 Market Snapshot
	2.2 Segment Snapshot
	2.3 Competitive Landscape Snapshot
	Chapter 3 Regulatory Affairs Outsourcing Market Variables and Trends
	
	3.1 Market Lineage Outlook
	3.2 Market Dynamics
	3.2.1 Market Driver Impact Analysis
	3.2.1.1 Changing regulatory landscape
	3.2.1.2 Entry of companies in the global market
	3.2.1.3 Life science companies focusing on their core competencies
	3.2.1.4 Economic and competitive pressures
	3.2.1.5 Demand for faster approval process for breakthrough drugs and devices
	3.2.1.6 Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
	3.2.2 Market Restraint Impact Analysis
	3.2.2.1 Risk associated with data security
	3.2.2.2 Monitoring issues and lack of standardization
	3.3 Industry Challenges
	3.3.1 Managing Relationships
	3.4 Major Deals and Strategic Alliances Analysis
	3.5 Service mapping, by drug/device lifecycle
	3.6 Service Price Analysis
	3.6.1 Organization Structure
	3.6.2 Price Level Analysis
	3.6.2.1 Regulatory Affairs Service Price Analysis By Phase
	3.6.2.2 Segement Category Level
	3.6.3 Unit Level
	3.6.4 Pricing Models
	3.7 Technology Landscape
	3.7.1 Existing and emerging use of technology and preferred tools
	3.7.2 Differentiating in-house tools vs widely available
	3.7.3 Tools that have seal of approval from regulatory authorities
	3.7.4 Key technology pillars
	3.8 COVID-19 Impact on Regulatory Affairs Outsourcing Market
	3.8.1 Covid-19 Impact on Clinical Trial Services Market
	3.8.2 Covid-19 Impact on Regulatory Services Market
	3.8.3 Covid-19 Impact on Key Market Players
	3.8.3.1 Medpace
	3.8.3.2 Icon plc
	3.8.3.3 Labcorp
	3.8.3.4 Ppd
	3.8.3.5 Charles River Laboratories
	3.8.4 Post Covid-19 Impact on the Market
	3.9 Top Regional Player Analysis
	3.10 Total Number of Clinical Trials (2021):
	3.10.1 Total Number of Clinical Trials (2021) by Major Countries In North America
	3.10.2 Total Number of Clinical Trials (2021) by Major Countries In Europe
	3.10.3 Total Number of Clinical Trials (2021) by Major Countries In Asia Pacific
	3.10.4 Total Number of Clinical Trials (2021) by Major Countries In Latin America
	3.10.5 Total Number of Clinical Trials (2021) by Major Countries In the Middle East & Africa
	3.11 Average Cost/Price of Clinical Trials
	3.11.1 Average Cost/Price of Clinical Trials by Phase
	3.11.2 Average Cost/Price of Clinical Trials by Therapeutic Areas
	3.11.3 Average Cost/Price of Clinical Trials by Major Countries/Region
	3.12 Cost Breakdown analysis for CRO's
	3.12.1 Percent of Outsourced vs In-house Clinical trial Categories
	3.13 Regulatory affairs: Industry Analysis Tools
	3.13.1 SWOT
	3.13.2 Porter’s analysis
	3.13.3 Macroeconomic Analysis
	Chapter 4 Regulatory Affairs Outsourcing Market: Service Segment Analysis
	
	4.1 Regulatory Affairs Outsourcing Market : Service Market Share Analysis, 2022 & 2030
	4.2 Regulatory Consulting
	4.2.1 Regulatory Consulting Market, 2018 - 2030 (USD Million)
	4.2.2 Strategy & Development Planning
	4.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
	4.2.3 QA Consulting
	4.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
	4.2.4 Others
	4.2.4.1 Others Market, 2018 - 2030 (USD Million)
	4.3 Legal Representation
	4.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
	4.4 Regulatory Writing & Publishing
	4.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
	4.5 Product registration & clinical trial applications
	4.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
	4.6 Regulatory Submissions
	4.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
	4.7 Regulatory Operations
	4.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
	4.8 Other services
	4.8.1 Other services Market, 2018 - 2030 (USD Million)
	Chapter 5 Regulatory Affairs Outsourcing Market: Category Estimates & Trend Analysis
	
	5.1 Regulatory Affairs Outsourcing Market : Category Market Share Analysis, 2022 & 2030
	5.2 Pharmaceutical
	5.2.1 Pharmaceutical Market, 2018 - 2030 (USD Million)
	5.2.2 Regulatory consulting
	5.2.2.1 Regulatory consulting Market, 2018 - 2030 (USD Million)
	5.2.2.2 Strategy & Development Planning
	5.2.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
	5.2.2.3 QA ConsultingPlanning
	5.2.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
	5.2.2.4 Others
	5.2.2.4.1 Others Market, 2018 - 2030 (USD Million)
	5.2.3 Legal Representation
	5.2.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
	5.2.4 Regulatory Writing & Publishing
	5.2.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
	5.2.5 Product registration & clinical trial applications
	5.2.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
	5.2.6 Regulatory Submissions
	5.2.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
	5.2.7 Regulatory Operations
	5.2.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
	5.2.8 Other services
	5.2.8.1 Other services Market, 2018 - 2030 (USD Million)
	5.3 Medical Device
	5.3.1 Medical Device Market, 2018 - 2030 (USD Million)
	5.3.2 Regulatory consulting
	5.3.2.1 Regulatory consulting Market, 2018 - 2030 (USD Million)
	5.3.2.2 Strategy & Development Planning
	5.3.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
	5.3.2.3 QA ConsultingPlanning
	5.3.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
	5.3.2.4 Others
	5.3.2.4.1 Others Market, 2018 - 2030 (USD Million)
	5.3.3 Legal Representation
	5.3.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
	5.3.4 Regulatory Writing & Publishing
	5.3.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
	5.3.5 Product registration & clinical trial applications
	5.3.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
	5.3.6 Regulatory Submissions
	5.3.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
	5.3.7 Regulatory Operations
	5.3.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
	5.3.8 Other services
	5.3.8.1 Other services Market, 2018 - 2030 (USD Million)
	Chapter 6 Regulatory Affairs Outsourcing Market: Company Size Estimates & Trend Analysis
	
	6.1 Regulatory Affairs Outsourcing Market: Company Size Market Share Analysis, 2022 & 2030
	6.2 Small Companies
	6.2.1 Small Companies Market, 2018 - 2030 (USD Million)
	6.3 Medium Companies
	6.3.1 Medium Companies Market, 2018 - 2030 (USD Million)
	6.4 Large Companies
	6.4.1 Large Companies Market, 2018 - 2030 (USD Million)
	Chapter 7 Regulatory Affairs Outsourcing Market: Indication Estimates & Trend Analysis
	
	7.1 Regulatory Affairs Outsourcing Market: Indication Market Share Analysis, 2022 & 2030
	7.2 Oncology
	7.2.1 Oncology Market, 2018 - 2030 (USD Million)
	7.3 Neurology
	7.3.1 Neurology Market, 2018 - 2030 (USD Million)
	7.4 Cardiology
	7.4.1 Cardiology Market, 2018 - 2030 (USD Million)
	7.5 Immunology
	7.5.1 Immunology Market, 2018 - 2030 (USD Million)
	7.6 Other Indications
	7.6.1 Other Indications Market, 2018 - 2030 (USD Million)
	Chapter 8 Regulatory Affairs Outsourcing Market: Product Stage Estimates & Trend Analysis
	
	8.1 Regulatory Affairs Outsourcing Market: Product Stage Market Share Analysis, 2022 & 2030
	8.2 Preclinical
	8.2.1 Preclinical Market, 2018 - 2030 (USD Million)
	8.3 Clinical
	8.3.1 Clinical Market, 2018 - 2030 (USD Million)
	8.4 Premarket Approval (PMA)
	8.4.1 Premarket Approval (PMA) Market, 2018 - 2030 (USD Million)
	Chapter 9 Regulatory Affairs Outsourcing Market: End-Use Estimates & Trend Analysis
	
	9.1 Regulatory Affairs Outsourcing Market: End-Use Market Share Analysis, 2022 & 2030
	9.2 Medical Device Companies
	9.2.1 Medical Device Companies Market, 2018 - 2030 (USD Million)
	9.3 Pharmaceutical Companies
	9.3.1 Pharmaceutical Companies Market, 2018 - 2030 (USD Million)
	9.4 Biotechnology Companies
	9.4.1 Biotechnology Companies Market, 2018 - 2030 (USD Million)
	Chapter 10 Regulatory Affairs Outsourcing Market: Regional Analysis
	
	10.1 Regulatory Affairs Outsourcing Market: Regional Outlook
	10.2 North America
	10.2.1 North America Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.2.2 U.S.
	10.2.2.1 U.S. Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.2.3 Canada
	10.2.3.1 Canada Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
	10.3 Europe
	10.3.1 Europe Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.2 U.K.
	10.3.2.1 UK Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.3 Germany
	10.3.3.1 Germany Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.4 France
	10.3.4.1 France Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.5 Italy
	10.3.5.1 Italy Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.6 Spain
	10.3.6.1 Spain Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.7 Russia
	10.3.7.1 Russia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.8 Sweden
	10.3.8.1 Sweden Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.9 Turkey
	10.3.9.1 Turkey Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.10 Netherlands
	10.3.10.1 Netherlands Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.11 Switzerland
	10.3.11.1 Switzerland Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.3.12 Europe CIS
	10.3.12.1 Europe CIS Countries Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4 Asia Pacific
	10.4.1 Asia Pacific Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.2 Japan
	10.4.2.1 Japan Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.3 China
	10.4.3.1 China Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
	10.4.4 India
	10.4.4.1 India Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.5 Australia
	10.4.5.1 Ausrtralia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.6 South Korea
	10.4.6.1 South Korea Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.7 Thailand
	10.4.7.1 Thailand Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.8 Indonesia
	10.4.8.1 Indonesia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.9 Malaysia
	10.4.9.1 Malaysia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.9 Singapore
	10.4.9.1 Singapore Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.10 Taiwan
	10.4.10.1 Taiwan Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.4.11 Asia Pacific CIS
	10.4.11.1 Asia Pacific CIS Countries Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.5 Latin America
	10.5.1 Latin America Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.5.2 Brazil
	10.5.2.1 Brazil Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.5.3 Mexico
	10.5.3.1 Mexico Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
	10.5.4 Argentina
	10.5.4.1 Argentina Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.5.5 Colombia
	10.5.5.1 Colombia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.5.6 Chile
	10.5.6.1 Chile Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6 Middle East & Africa
	10.6.1 Middle East & Africa Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6.2 South Africa
	10.6.2.1 South Africa Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6.3 Saudi Arabia
	10.6.3.1 Saudi Arabia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6.4 UAE
	10.6.4.1 UAE Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6.5 Egypt
	10.6.5.1 Egypt Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	10.6.6 Israel
	10.6.6.1 Israel Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
	Chapter 11 Competitive Landscape
	
	11.1 Company Market Share Analysis (2022)
	11.2 Service Heat map analysis
	11.3 Company profiles
	11.3.1 Accell Clinical Research, LLC
	11.3.1.1 Company overview
	11.3.1.2 Financial performance
	11.3.1.3 Service benchmarking
	11.3.1.4 Strategic initiatives
	11.3.2 Genpact
	11.3.2.1 Company overview
	11.3.2.2 Financial performance
	11.3.2.3 Service benchmarking
	11.3.2.4 Strategic initiatives
	11.3.3 CRITERIUM, INC
	11.3.3.1 Company overview
	11.3.3.2 Financial performance
	11.3.3.3 Service benchmarking
	11.3.3.4 Strategic initiatives
	11.3.4 Promedica International
	11.3.4.1 Company overview
	11.3.4.2 Financial performance
	11.3.4.3 Service benchmarking
	11.3.4.4 Strategic initiatives
	11.3.5 WuXi AppTec
	11.3.5.1 Company overview
	11.3.5.2 Financial performance
	11.3.5.3 Service benchmarking
	11.3.5.4 Strategic initiatives
	11.3.6 Medpace
	11.3.6.1 Company overview
	11.3.6.2 Financial performance
	11.3.6 3 Service benchmarking
	11.3.6.4 Strategic initiatives
	11.3.7 Charles River Laboratories
	11.3.7.1 Company overview
	11.3.7.2 Financial performance
	11.3.7.3 Service benchmarking
	11.3.7.4 Strategic initiatives
	11.3.8 ICON plc
	11.3.8.1 Company overview
	11.3.8.2 Financial performance
	11.3.8.3 Service benchmarking
	11.3.8.4 Strategic initiatives
	11.3.9 Covance, Inc. (Labcorp Drug Development)
	11.3.9.1 Company overview
	11.3.9.2 Financial performance
	11.3.9.3 Service benchmarking
	11.3.9.4 Strategic initiatives
	11.3.10 Parexel International Corporation
	11.3.10.1 Company overview
	11.3.10.2 Financial performance
	11.3.10.3 Service benchmarking
	11.3.10.4 Strategic initiatives
	11.3.11 Freyr
	11.3.11.1 Company overview
	11.3.11.2 Financial performance
	11.3.11.3 Service benchmarking
	11.3.11.4 Strategic initiatives
	11.3.12 PHARMALEX GMBH
	11.3.12.1 Company overview
	11.3.12.2 Financial performance
	11.3.12.3 Service benchmarking
	11.3.12.4 Strategic initiatives
	11.3.13 NDA Group AB
	11.3.13.1 Company overview
	11.3.13 2 Financial performance
	11.3.13.3 Service benchmarking
	11.3.13.4 Strategic initiatives
	11.3.14 Pharmexon
	11.3.14.1 Company overview
	11.3.14 2 Financial performance
	11.3.14.3 Service benchmarking
	11.3.14.4 Strategic initiatives
	11.3.15 Qvigilance
	11.3.15.1 Company overview
	11.3.15 2 Financial performance
	11.3.15.3 Service benchmarking
	11.3.15.4 Strategic initiatives
	11.3.16 BlueReg
	11.3.16.1 Company overview
	11.3.16 2 Financial performance
	11.3.16.3 Service benchmarking
	11.3.16.4 Strategic initiatives
	11.3.17 Cambridge Regulatory Services
	11.3.17.1 Company overview
	11.3.17 2 Financial performance
	11.3.17.3 Service benchmarking
	11.3.17.4 Strategic initiatives
	11.3.18 APCER Life Sciences, Inc.
	11.3.18.1 Company overview
	11.3.18 2 Financial performance
	11.3.18.3 Service benchmarking
	11.3.18.4 Strategic initiatives
	11.3.19 Real Regulatory Ltd
	11.3.19.1 Company overview
	11.3.19 2 Financial performance
	11.3.19.3 Service benchmarking
	11.3.19.4 Strategic initiatives
	11.3.20 VCLS
	11.3.20.1 Company overview
	11.3.20 2 Financial performance
	11.3.20.3 Service benchmarking
	11.3.20.4 Strategic initiatives
	11.3.21 PrimeVigilance
	11.3.21.1 Company overview
	11.3.21 2 Financial performance
	11.3.21.3 Service benchmarking
	11.3.21.4 Strategic initiatives
	11.3.22 ProPharma Group MIS Limited
	11.3.22.1 Company overview
	11.3.22 2 Financial performance
	11.3.22.3 Service benchmarking
	11.3.22.4 Strategic initiatives
	11.3.23 Regulatory Pharma Net srl
	11.3.23.1 Company overview
	11.3.23 2 Financial performance
	11.3.23.3 Service benchmarking
	11.3.23.4 Strategic initiatives
	11.3.24 ZEINCRO
	11.3.24.1 Company overview
	11.3.24 2 Financial performance
	11.3.24.3 Service benchmarking
	11.3.24.4 Strategic initiatives
	11.3.25 BioMapas
	11.3.25.1 Company overview
	11.3.25 2 Financial performance
	11.3.25.3 Service benchmarking
	11.3.25.4 Strategic initiatives
	11.3.26 REGENOLD GMBH
	11.3.26.1 Company overview
	11.3.26 2 Financial performance
	11.3.26.3 Service benchmarking
	11.3.26.4 Strategic initiatives
	List of Tables
	
	Table 1 Average price range by service type
	Table 2 User fees as charged by U.S. FDA
	Table 3 Application fees for NCEs and generics
	Table 4 Emergence, applications, uses of the following key technology pillars
	Table 5 Impact of COVID-19 on new patients entering trials
	Table 6 Impact of COVID-19 on other therapeutic areas
	Table 7 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Service, 2018 - 2030 (USD Millions)
	Table 8 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Regulatory Consulting, 2018 - 2030 (USD Millions)
	Table 9 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Category, 2018 - 2030 (USD Millions)
	Table 10 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Company Size, 2018 - 2030 (USD Millions)
	Table 11 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Indication, 2018 - 2030 (USD Millions)
	Table 12 Estimated numbers of survivors for the 10 most prevalent cancers among people in the United States as of January 1, 2022
	Table 13 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Product Stage, 2018 - 2030 (USD Millions)
	Table 14 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By End-Use, 2018 - 2030 (USD Millions)
	Table 15 The export and import values for U.S. Medical Devices from 2016 to 2020 in USD billion
	Table 16 Company Market Share, 2022
	Table 17 Key companies undertaking expansions.
	Table 18 Key companies undergoing collaborations, partnerships, agreements.
	Table 19 Key companies launching new products.
	Table 20 Key companies undergoing acquisitions.
	List of Figures
	
	Fig. 1 Regulatory Affairs Outsourcing Market Segmentation
	Fig. 2 Information Procurement
	Fig. 3 Data Analysis Models
	Fig. 4 Market Formulation And Validation
	Fig. 5 Data Validating & Publishing
	Fig. 6 Market snapshot
	Fig. 7 Segment snapshot
	Fig. 8 Segment snapshot
	Fig. 9 Segment snapshot
	Fig. 10 Competitive landscape snapshot
	Fig. 11 Regulatory Affairs Market Value, 2022 (USD Million)
	Fig. 12 Regulatory Affairs Outsourcing Market Dynamics
	Fig. 13 Number of Trials, By WHO Regions
	Fig. 14 Personalized Medicine as a percentage of CDER approved novel molecules.
	Fig. 15 Generics service demand based on lifecycle stage
	Fig. 16 Innovative drugs service demand based on lifecycle stage
	Fig. 17 Biologics/ATMPs/biosimilars service demand based on lifecycle stage
	Fig. 18 Medical devices service demand based on lifecycle stage
	Fig. 19 Organization Structure - Regulatory Affairs
	Fig. 20 Regulatory Affairs Phase Wise Price Distribution (In Percent share)
	Fig. 21 Usage/adoption of cloud technology for regulatory space
	Fig. 22 Top Regional Player Analysis
	Fig. 23 Total number of Clinical Trials (2021)
	Fig. 24 Countries in North America
	Fig. 25 Countries by Europe
	Fig. 26 Countries by Asia Pacific
	Fig. 27 Countries by Latin America
	Fig. 28 Countries by Middle East & Africa
	Fig. 29 Average Cost by Phase
	Fig. 30 Clinical Trial Cost Per Indication (millions)
	Fig. 31 Average Cost of Clinical Trials by Major Countries
	Fig. 32 Percent of Outsourced vs In-house of Key Clinical Trial Categories (Trend across 2018-2020)
	Fig. 33 SWOT
	Fig. 34 Regulatory Affairs Outsourcing Market: PORTER’s Analysis
	Fig. 35 Regulatory Affairs Outsourcing Market: PEST Analysis
	Fig. 36 Regulatory Affairs Outsourcing Market, by Service: Key Takeaways
	Fig. 37 Regulatory Affairs Outsourcing Market, by Service: Market Share, 2022 & 2030
	Fig. 38 Regulatory consulting market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 39 Strategy & development planning market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 40 QA consulting market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 41 Others market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 42 Legal representation market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 43 Regulatory writing & publishing market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 44 Product registration & clinical trial applications market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 45 Regulatory submissions market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 46 Regulatory operations market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 47 Other services market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 48 Regulatory Affairs Outsourcing Market, by Category: Key Takeaways
	Fig. 49 Regulatory Affairs Outsourcing Market, by Category: Market Share, 2022 & 2030
	Fig. 50 Pharmaceuticals Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
	Fig. 51 Pharmaceuticals Regulatory Affairs Outsourcing Market by regulatory consulting, 2018 - 2030 (USD Million)
	Fig. 52 Pharmaceutical Regulatory Affairs Outsourcing Market by Strategy & Development Planning, 2018 - 2030 (USD Million)
	Fig. 53 Pharmaceutical Regulatory Affairs Outsourcing Market by QA consulting market, 2018 - 2030 (USD Million)
	Fig. 54 Pharmaceutical regulatory affairs outsourcing market by others, 2018 - 2030 (USD Million)
	Fig. 55 Pharmaceuticals Regulatory Affairs Outsourcing Market, by legal representation, 2018 - 2030 (USD Million)
	Fig. 56 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory writing & publishing, 2018 - 2030 (USD Million)
	Fig. 57 Pharmaceuticals Regulatory Affairs Outsourcing Market, by product registration & clinical trial market, 2018 - 2030 (USD Million)
	Fig. 58 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory submissions market, 2018 - 2030 (USD Million)
	Fig. 59 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory operations market, 2018 - 2030 (USD Million)
	Fig. 60 Pharmaceuticals Regulatory Affairs Outsourcing Market, by other services market, 2018 - 2030 (USD Million)
	Fig. 61 Medical Devices Regulatory Affairs Outsourcing market, 2018 - 2030 (USD Million)
	Fig. 62 Medical devices regulatory affairs outsourcing market by regulatory consulting market, 2018 - 2030 (USD Million)
	Fig. 63 Medical devices Regulatory Affairs Outsourcing Market by strategy & development planning market, 2018 - 2030 (USD Million)
	Fig. 64 Medical devices Regulatory Affairs Outsourcing Market by QA consulting market, 2018 - 2030 (USD Million)
	Fig. 65 Medical devices Regulatory Affairs Outsourcing Market by Others market, 2018 - 2030 (USD Million)
	Fig. 66 Medical devices Regulatory Affairs Outsourcing Market by legal representation market, 2018 - 2030 (USD Million)
	Fig. 67 Medical devices Regulatory Affairs Outsourcing Market by regulatory writing and publishing market, 2018 - 2030 (USD Million)
	Fig. 68 Medical devices Regulatory Affairs Outsourcing Market by product registration & clinical trial applications, 2018 - 2030 (USD Million)
	Fig. 69 Medical devices Regulatory Affairs Outsourcing Market by regulatory submissions market, 2018 - 2030 (USD Million)
	Fig. 70 Medical devices Regulatory Affairs Outsourcing Market by regulatory operations market, 2018 - 2030 (USD Million)
	Fig. 71 Medical devices Regulatory Affairs Outsourcing Market by other services, 2018 - 2030 (USD Million)
	Fig. 72 Regulatory Affairs Outsourcing Market, by Company size: Key Takeaways
	Fig. 73 Regulatory Affairs Outsourcing Market, by Company Size: Market Share, 2022 & 2030
	Fig. 74 Small companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 75 Medium companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 76 Large companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 77 Regulatory Affairs Outsourcing Market, by Indication: Key Takeaways
	Fig. 78 Regulatory Affairs Outsourcing Market, by Indication: Market Share, 2022 & 2030
	Fig. 79 Oncology market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 80 Neurology market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 81 Cardiology market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 82 Immunology market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 83 Other indications market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 84 Regulatory Affairs Outsourcing Market, by Product Stage: Key Takeaways
	Fig. 85 Regulatory Affairs Outsourcing Market, by Product Stage: Market Share, 2022 & 2030
	Fig. 86 Preclinical market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 87 Clinical market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 88 Percentage of Registered Studies by Location (as of February 17, 2023)
	Fig. 89 Premarket approval (PMA) market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 90 Regulatory Affairs Outsourcing Market, by End-Use: Key Takeaways
	Fig. 91 Regulatory Affairs Outsourcing Market, by End-Use: Market Share, 2022 & 2030
	Fig. 92 Medical device companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 93 Pharmaceutical companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 94 Biotechnology companies market estimates & forecasts, 2018 - 2030 (USD Million)
	Fig. 95 Regulatory affairs outsourcing market revenue, by region, 2022 & 2030 (USD Million)
	Fig. 96 Regional marketplace: Key takeaways (North America & Europe)
	Fig. 97 Regional marketplace: Key takeaways (Asia Pacific, Latin America, and MEA)
	Fig. 98 North America market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 99 Key country dynamics
	Fig. 100 U.S. Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 101 Key country dynamics
	Fig. 102 Canada regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 103 Europe Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 104 Key country dynamics
	Fig. 105 UK regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 106 Key country dynamics
	Fig. 107 Germany Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 108 Key country dynamics
	Fig. 109 France Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 110 Key country dynamics
	Fig. 111 Italy regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 112 Key country dynamics
	Fig. 113 Spain regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 114 Russia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 115 Key country dynamics
	Fig. 116 Sweden Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 117 Turkey regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 118 Netherlands regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 119 Key country dynamics
	Fig. 120 Switzerland Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 121 Europe CIS regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 122 Asia Pacific market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 123 Key country dynamics
	Fig. 124 Japan regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 125 Key country dynamics
	Fig. 126 China regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 127 Key country dynamics
	Fig. 128 India regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 129 Key country dynamics
	Fig. 130 Australia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 131 Key country dynamics
	Fig. 132 South Korea regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 133 Key country dynamics
	Fig. 134 Thailand regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 135 Indonesia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 136 Malaysia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 137 Singapore regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 138 Taiwan regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 139 Asia Pacific CIS regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 140 Latin America market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 141 Key country dynamics
	Fig. 142 Brazil regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 143 Key country dynamics
	Fig. 144 Mexico regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 145 Reimbursement scenario
	Fig. 146 Key country dynamics
	Fig. 147 Argentina regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 148 Colombia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 149 Chile regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 150 Middle East & Africa regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 151 Key country dynamics
	Fig. 152 South Africa regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 153 Key country dynamics
	Fig. 154 Saudi Arabia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 155 Key country dynamics
	Fig. 156 UAE regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 157 Egypt regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 158 Israel regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
	Fig. 159 Company Market Share Analysis, 2022
	Fig. 160 Strategic framework