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The report also covers key industry developments, and Porter’s Five Force analysis which identifies bargaining power of suppliers, bargaining power of buyers, threat from new entrants, threat from substitutes, and degree of competition in the regulatory affairs outsourcing market. Ecosystem analysis which identifies key stakeholders in the regulatory affairs outsourcing market is covered in the report.
Global Regulatory Affairs Outsourcing Market: Scope of the Report
The regulatory affairs outsourcing market has been segmented based on services and region. By services, the market is segmented into regulatory submissions; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others. Geographically, the report classifies the global regulatory affairs outsourcing market into North America, Europe, Asia Pacific (APAC), Middle East & Africa (MEA), and South America; the regions are analyzed in terms of revenue generation. Furthermore, region-wise prominent countries covered in the report include the U.S, Canada, U.K., Germany, France, Japan, China, India, GCC countries, South Africa, and Brazil.
Global trends have also been included in the regulatory affairs outsourcing study. Additionally, the report covers segment-wise comparison matrix, market attractiveness analysis, and market positioning of key players for all regions covered in the scope of study.
Comparison matrix includes segment growth matrix, 2016– 2026 (%), segment revenue contribution, 2016 - 2026 (%), and segment compound annual growth rate (CAGR %). Market attractiveness identifies and compares market attractiveness of segments based on CAGR and market share index across North America, Europe, Asia Pacific, Middle East & Africa (MEA), and South America.
Global Regulatory Affairs Outsourcing Market: Research Methodology
Secondary research sources typically include, but are not limited to company websites, annual reports, financial reports, broker reports, investor presentations, and SEC filings, internal and external proprietary databases, and relevant patent and regulatory databases, national government documents, vendors whitepapers, statistical databases, and market reports, news articles, press releases, and webcasts specific to companies operating in the market.
Primary research involves e-mail interactions, telephonic interviews, and face-to-face interviews for each market, category, segment, and sub-segment across geographies. We conduct primary interviews on an ongoing basis with industry participants and commentators in order to validate the data and analysis. Primary interviews provide first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook, etc. These help us to validate and strengthen secondary research findings. These also help develop the analysis team’s market expertise and understanding.
Global Regulatory Affairs Outsourcing Market: Competitive Dynamics
The report includes competition landscape which comprises market share analysis, market positioning of major players in the regulatory affairs outsourcing market based on their 2017 revenues, and profiles of major players. Competition matrix benchmarks leading players on the basis of their capabilities and potential to grow. Factors including market position, offerings, and R&D focus are attributed to a company’s capabilities. Factors including top line growth, market share, segment growth, infrastructure facilities, and future outlook are attributed to a company’s potential to grow. This section also identifies and includes various recent developments carried out by the leading players of the regulatory affairs outsourcing market.
Company profiling includes company overview, major business strategies adopted, SWOT analysis, and market revenues between 2016 and 2018. The players profiled in the global regulatory affairs outsourcing market include PAREXEL International Corporation, WuXi AppTec, IQVIA Holdings Inc., Accell Clinical Research LLC, Clinilabs Inc., Criterium, Inc., Pharmaceutical Product Development, (PPD) LLC, Promedica International, Charles River Laboratories International, Inc., ICON plc., BlueReg Group, Covance, Inc., Dr. Regenold GmbH,FMD K&L, Genpact Limited, ProductLife Group S.A., Intertek Group plc,Kinapse Ltd, Medpace, Inc., Navitas Life Sciences, PharmaLex GmbH, PRA Health Sciences, Inc., Syneos Health, Inc., and Verisk 3E.
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Regulatory Affairs Outsourcing Market Analysis, by Services
- Regulatory Submissions
- Clinical Trial Applications and Product Registrations
- Regulatory Writing and Publishing
- Regulatory Consulting and Legal Representation
Additionally, the report provides cross-sectional analysis of the regulatory affairs outsourcing market with respect to the following geographical segments:
- North America
- Rest of North America
- Rest of Europe
- Asia Pacific
- South Korea
- Rest of Asia Pacific
- Middle East & Africa
- Saudi Arabia
- South Africa
- Rest of Middle East & Africa
- South America
- Rest of South America
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