Opportunities Preloader

Please Wait.....

Report

Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other Services), By Category (Pharmaceutical, Medical Device), By Company Size (Small Companies, Medium Companies, Large Companies), By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications), By Product Stage (Preclinical, Clinical, Premarket Approval), By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), By Region and Competition

Market Report I 2023-08-01 I 118 Pages I TechSci Research

Regulatory Affairs Outsourcing Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to growing research and development activities along with augmenting the volume of clinical trial applications and product registrations. Similarly, growing regulations taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among life science companies. In 2020, Eli Lilly entered into an agreement to acquire Dermira's immunology portfolio. In addition, the COVID-19 pandemic created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth. Increasing globalization
Increasing globalization had a significant impact on the growth of the Global Regulatory Affairs Outsourcing market. As companies expand their operations globally, they are faced with the challenge of complying with different regulatory frameworks in various regions. This challenge has driven the demand for regulatory affairs outsourcing services as companies look for specialized service providers who can help them navigate the complexities of different regulatory frameworks.
One of the key benefits of outsourcing regulatory affairs services is the expertise that service providers can bring to the table. Service providers who specialize in regulatory affairs have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. This expertise is critical in ensuring that companies comply with the applicable regulations and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to focus on their core competencies, such as product development and marketing, while leaving compliance-related activities to be specialized service providers. This can help companies improve their operational efficiency, reduce costs, and improve their bottom line. Furthermore, advancements in technology, such as cloud-based regulatory information management systems, have made it easier for companies to outsource regulatory affairs services across different regions. These systems allow service providers to access and manage regulatory information securely, regardless of location. This has made it easier for companies to work with service providers who are located in different parts of the world.
Rising regulatory complexities
Regulatory complexities play a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory authorities around the world are increasing their scrutiny of various industries, including healthcare, pharmaceuticals, and medical devices. Compliance with these regulations can be time-consuming and complex, requiring significant resources and expertise. Outsourcing regulatory affairs services can help companies stay on top of regulatory changes and ensure compliance with applicable regulations. Regulatory affairs service providers have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, quality assurance, and others. Furthermore, regulatory affairs service providers can help companies navigate the complex regulatory requirements of different regions. This includes providing guidance on product labeling and packaging requirements, as well as ensuring compliance with Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs). Outsourcing regulatory affairs services can help companies reduce the risk of costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line.
Growing demand for specialized expertise
Specialized expertise has been a key factor in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory affairs are a complex and specialized field that requires in-depth knowledge of various regulatory frameworks, including laws, regulations, and guidelines. As regulatory requirements become increasingly complex and stringent, companies are facing a growing need for specialized expertise to ensure compliance and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to tap into the specialized expertise of regulatory affairs service providers. These providers have extensive knowledge of the regulatory landscape in different regions, as well as the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, and quality assurance, among others.
Furthermore, regulatory affairs service providers can provide specialized expertise in specific areas, such as medical devices, biologics, and pharmaceuticals. This expertise can be particularly valuable for companies that lack in-house regulatory affairs expertise in these areas. By outsourcing regulatory affairs services to specialized service providers, companies can ensure that they have access to the expertise they need to comply with the applicable regulatory requirements. Specialized expertise can help companies stay up to date with the latest regulatory developments and changes. Regulatory affairs service providers are constantly monitoring regulatory changes in different regions and can provide expert guidance on how these changes may impact a company's products or operations.
Cost savings
Cost savings is a significant factor in the growth of the Global Regulatory Affairs Outsourcing Market. Compliance with regulatory requirements can be time-consuming and costly, requiring significant resources and expertise. Companies that lack in-house regulatory affairs expertise may need to hire and train staff or use costly external consultants to ensure compliance. Outsourcing regulatory affairs services can provide significant cost savings for companies. Regulatory affairs service providers can offer specialized expertise and resources, often at a lower cost than hiring and training in-house staff or using external consultants. Outsourcing can provide a more flexible and scalable approach to regulatory affairs, allowing companies to scale their regulatory affairs resources up or down as needed, depending on business needs.
Outsourcing regulatory affairs services can help companies avoid costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line. Outsourcing regulatory affairs services can help companies improve their operational efficiency. By outsourcing regulatory affairs services, companies can free up internal resources to focus on their core business activities, such as product development and marketing. This can help improve productivity and profitability while still ensuring compliance with regulatory requirements.
Advancements in technology
Advancements in technology have played a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. The increasing adoption of digital technologies has transformed many aspects of the regulatory affairs landscape, creating new opportunities for outsourcing service providers. One major factor that influences the growth of the market is the automation of regulatory affairs processes. The use of advanced software systems and artificial intelligence (AI) tools can help streamline regulatory affairs workflows, reducing the time and effort required to perform compliance-related activities. For example, AI can be used to review large volumes of regulatory documents, helping to identify potential issues and improve the accuracy of regulatory submissions.
Technology has enabled greater collaboration and communication between regulatory affairs service providers and their clients. Cloud-based platforms and other collaboration tools make it easier for regulatory affairs professionals to work together, regardless of their location. This can help improve efficiency and reduce the time and cost associated with regulatory affairs processes. Another area where technology has an impact on the use of real-time data monitoring and analytics. Advanced data analytics tools can help regulatory affairs professionals identify emerging regulatory trends and potential compliance issues, allowing them to proactively address these issues before they become problems. Finally, technology has enabled greater transparency and accountability in the regulatory affairs process. Digital systems and tools make it easier to track compliance-related activities and provide audit trails, improving compliance and reducing the risk of non-compliance.
Recent Development

In 2021, WIRB-Copernicus Group (WCG) launched a new service called WCG Oncology, which provides comprehensive regulatory and ethical review services for oncology clinical trials.
In 2020, Kinapse (a subsidiary of Syneos Health) launched a new service called Kinapse Quality Labs, which uses advanced data analytics and AI to help clients optimize their regulatory compliance processes.
In 2020, IQVIA launched a new suite of regulatory information management solutions designed to help clients manage the regulatory submission process more efficiently.
In 2019, Qserve Group launched a new platform called QserveConnect, which provides clients with on-demand access to a range of regulatory affairs services, including regulatory strategy, clinical evaluation, and quality management.
In 2019, Accenture launched its Regulatory and Compliance Analytics Solution, a suite of digital tools and services designed to help companies manage regulatory compliance more effectively.
In 2018, Parexel launched its new Regulatory Outsourcing service, designed to help clients navigate complex regulatory environments and improve their time to market.
Market Segmentation

Global Regulatory Affairs Outsourcing Market can be segmented by service, category, company size, indication, production stage, end-use, and by region. Based on service, the market can be segmented into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, and other services. Based on category, the market can be divided into pharmaceutical and medical devices. Based on company size, the market can be segmented into small companies, medium companies, and large companies. Based on indication, the market can be differentiated into oncology, neurology, cardiology, immunology, and other indications. Based on the product stage, the market can be segmented into preclinical, clinical, and premarket approval. Based on end use, the market can be differentiated into medical device companies, pharmaceutical companies, and biotechnology companies.

Market Players
Accell Clinical Research, LLC., Genpact Ltd., CRITERIUM, INC., Promedica International. , WuXi AppTec Co Ltd., Medpace Inc., Charles River Laboratories Inc., ICON plc., Covance, Inc.., Parexel International Corporation., Freyr AS, PHARMALEX GMBH, NDA Group AB, Pharmexon Consulting, Qvigilance, and BlueReg Group are some of the leading players operating in the Global Regulatory Affairs Outsourcing Market.
Report Scope:
In this report, Global Regulatory Affairs Outsourcing market has been segmented into the following categories, in addition to the industry trends, which have also been detailed below:
Regulatory Affairs Outsourcing Market, By Service:
o Regulatory Consulting
o Legal Representation
o Regulatory Writing & Publishing
o Product registration & clinical trial applications
o Regulatory Submissions
o Regulatory Operations
o Other services
Regulatory Affairs Outsourcing Market, By Category:
o Pharmaceutical
o Medical Device
Regulatory Affairs Outsourcing Market, By Company Size:
o Small Companies
o Medium Companies
o Large Companies
Regulatory Affairs Outsourcing Market, By Indication:
o Oncology
o Neurology
o Cardiology
o Immunology
o Other Indications
Regulatory Affairs Outsourcing Market, By Product Stage:
o Preclinical, Clinical
o Premarket Approval
Regulatory Affairs Outsourcing Market, By End Use:
o Medical Device Companies
o Pharmaceutical Companies
o Biotechnology Companies
Regulatory Affairs Outsourcing Market, By Region:
o North America
? United States
? Canada
? Mexico
o Europe
? France
? Germany
? United Kingdom
? Italy
? Spain
o Asia Pacific
? China
? India
? Japan
? South Korea
? Australia
o South America
? Brazil
? Argentina
? Colombia
o Middle East & Africa
? South Africa
? Saudi Arabia
? UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market.
Available Customizations:
With the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).

1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Regulatory Affairs Outsourcing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
5.2.2. By Category (Pharmaceutical, Medical Device)
5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
5.2.8. By Company (2022)
5.3. Market Map
5.3.1 By Service
5.3.2 By Category
5.3.3 By Company Size
5.3.4 By Indication
5.3.5 By Product Stage
5.3.6 By End Use
6. North America Regulatory Affairs Outsourcing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
6.2.2. By Category (Pharmaceutical, Medical Device)
6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
6.2.7. By Country
6.3. North America: Country Analysis
6.3.1. United States Regulatory Affairs Outsourcing Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Service
6.3.1.2.2. By Category
6.3.1.2.3. By Company Size
6.3.1.2.4. By Indication
6.3.1.2.5. By Product Stage
6.3.1.2.6. By End Use
6.3.2. Canada Regulatory Affairs Outsourcing Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Service
6.3.2.2.2. By Category
6.3.2.2.3. By Company Size
6.3.2.2.4. By Indication
6.3.2.2.5. By Product Stage
6.3.2.2.6. By End Use
6.3.3. Mexico Regulatory Affairs Outsourcing Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Service
6.3.3.2.2. By Category
6.3.3.2.3. By Company Size
6.3.3.2.4. By Indication
6.3.3.2.5. By Product Stage
6.3.3.2.6. By End Use
7. Europe Regulatory Affairs Outsourcing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
7.2.2. By Category (Pharmaceutical, Medical Device)
7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
7.2.7. By Country
7.3. Europe: Country Analysis
7.3.1. France Regulatory Affairs Outsourcing Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Service
7.3.1.2.2. By Category
7.3.1.2.3. By Company Size
7.3.1.2.4. By Indication
7.3.1.2.5. By Product Stage
7.3.1.2.6. By End Use
7.3.2. Germany Regulatory Affairs Outsourcing Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Service
7.3.2.2.2. By Category
7.3.2.2.3. By Company Size
7.3.2.2.4. By Indication
7.3.2.2.5. By Product Stage
7.3.2.2.6. By End Use
7.3.3. United Kingdom Regulatory Affairs Outsourcing Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Service
7.3.3.2.2. By Category
7.3.3.2.3. By Company Size
7.3.3.2.4. By Indication
7.3.3.2.5. By Product Stage
7.3.3.2.6. By End Use
7.3.4. Italy Regulatory Affairs Outsourcing Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Service
7.3.4.2.2. By Category
7.3.4.2.3. By Company Size
7.3.4.2.4. By Indication
7.3.4.2.5. By Product Stage
7.3.4.2.6. By End Use
7.3.5. Spain Regulatory Affairs Outsourcing Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Service
7.3.5.2.2. By Category
7.3.5.2.3. By Company Size
7.3.5.2.4. By Indication
7.3.5.2.5. By Product Stage
7.3.5.2.6. By End Use
8. Asia-Pacific Regulatory Affairs Outsourcing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
8.2.2. By Category (Pharmaceutical, Medical Device)
8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
8.2.7. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Regulatory Affairs Outsourcing Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Service
8.3.1.2.2. By Category
8.3.1.2.3. By Company Size
8.3.1.2.4. By Indication
8.3.1.2.5. By Product Stage
8.3.1.2.6. By End Use
8.3.2. India Regulatory Affairs Outsourcing Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Service
8.3.2.2.2. By Category
8.3.2.2.3. By Company Size
8.3.2.2.4. By Indication
8.3.2.2.5. By Product Stage
8.3.2.2.6. By End Use
8.3.3. Japan Regulatory Affairs Outsourcing Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Service
8.3.3.2.2. By Category
8.3.3.2.3. By Company Size
8.3.3.2.4. By Indication
8.3.3.2.5. By Product Stage
8.3.3.2.6. By End Use
8.3.4. South Korea Regulatory Affairs Outsourcing Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Service
8.3.4.2.2. By Category
8.3.4.2.3. By Company Size
8.3.4.2.4. By Indication
8.3.4.2.5. By Product Stage
8.3.4.2.6. By End Use
8.3.5. Australia Regulatory Affairs Outsourcing Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Service
8.3.5.2.2. By Category
8.3.5.2.3. By Company Size
8.3.5.2.4. By Indication
8.3.5.2.5. By Product Stage
8.3.5.2.6. By End Use
9. South America Regulatory Affairs Outsourcing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
9.2.2. By Category (Pharmaceutical, Medical Device)
9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
9.2.7. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Regulatory Affairs Outsourcing Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Service
9.3.1.2.2. By Category
9.3.1.2.3. By Company Size
9.3.1.2.4. By Indication
9.3.1.2.5. By Product Stage
9.3.1.2.6. By End Use
9.3.2. Argentina Regulatory Affairs Outsourcing Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Service
9.3.2.2.2. By Category
9.3.2.2.3. By Company Size
9.3.2.2.4. By Indication
9.3.2.2.5. By Product Stage
9.3.2.2.6. By End Use
9.3.3. Colombia Regulatory Affairs Outsourcing Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Service
9.3.3.2.2. By Category
9.3.3.2.3. By Company Size
9.3.3.2.4. By Indication
9.3.3.2.5. By Product Stage
9.3.3.2.6. By End Use
10. Middle East and Africa Regulatory Affairs Outsourcing Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
10.2.2. By Category (Pharmaceutical, Medical Device)
10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
10.2.7. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Regulatory Affairs Outsourcing Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Service
10.3.1.2.2. By Category
10.3.1.2.3. By Company Size
10.3.1.2.4. By Indication
10.3.1.2.5. By Product Stage
10.3.1.2.6. By End Use
10.3.2. Saudi Arabia Regulatory Affairs Outsourcing Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Service
10.3.2.2.2. By Category
10.3.2.2.3. By Company Size
10.3.2.2.4. By Indication
10.3.2.2.5. By Product Stage
10.3.2.2.6. By End Use
10.3.3. UAE Regulatory Affairs Outsourcing Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Service
10.3.3.2.2. By Category
10.3.3.2.3. By Company Size
10.3.3.2.4. By Indication
10.3.3.2.5. By Product Stage
10.3.3.2.6. By End Use
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Development
12.2. Mergers & Acquisitions
12.3. Product Launches
13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis
14. Porters Five Forces Analysis
14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products
15. Competitive Landscape
15.1. Business Overview
15.2. Product Offerings
15.3. Recent Developments
15.4. Financials (As Reported)
15.5. Key Personnel
15.6. SWOT Analysis
15.6.1 Accell Clinical Research, LLC.
15.6.2 Genpact Ltd.
15.6.3 CRITERIUM, INC.
15.6.4 Promedica International.
15.6.5 WuXi AppTec Co Ltd.
15.6.6 Medpace Inc.
15.6.7 Charles River Laboratories.
15.6.8 ICON plc.
15.6.9 Covance, Inc.
15.6.10 Parexel International Corporation.
15.6.11 Freyr AS
15.6.12 PHARMALEX GMBH
15.6.13 NDA Group AB
15.6.14 Pharmexon Consulting.
15.6.15 Qvigilance
15.6.16 BlueReg Group.
16. Strategic Recommendations

  • Not Sure / Need Reassuring
    • Confirm Content
      • Content is provided by our partners and every effort is made to make Market Report details as clear as possible. If you are not sure the exact content you require is included in this study you can Contact us to double check. To do this you can:

        Use the ‘? ASK A QUESTION’ below the license / prices and to the right of this box. This will come directly to our team who will work on dealing with your request as soon as possible.

        Write to directly on support@scotts-international.com with details. Please include as much information as possible including the name of report or link so our staff will be able to work on you request.

        Telephone us directly on 0048 603 394 346 and an experienced member of team will be on hand to answer.

    • Sample Pages
      • With the vast majority of our partners we can obtain Sample Pages to support your decision. This is something we can arrange without revealing your personal details.

        It is important to note that we will not be able to provide you the exact data or statistics such as Market Size and Forecasts. Sample pages usually confirm the layout or the Categories included in Charts and Graphs, excluding specific data.

        To ask for Sample Pages by contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.

    • Check for Alternatives
      • Whilst we try to make our online platform as easy to use as possible there is always the possibility that a better alternative has not been found in your search.

        To avoid this possibility Contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346 and a Senior Team Member can review your requirements and send a list of possibilities with opinions and recommendations.

  • Prices / Formats / Delivery
    • Prices
      • All prices are set by our partners and should be exactly the same as those listed on their own websites. We work on a Revenue share basis ensuring that you never pay more than what is offered elsewhere.

        Should you find the price cheaper on another platform we recommend you to Contact us as we should be able to match this price. You can Contact us though through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.

    • Discounts
      • As we work in close partnership with our Partners from time to time we can secure discounts and assist with negotiations, this is part of our personalised service to you.

        Discounts can sometimes be arranged for speedily placed orders; multiple report purchases or Higher License purchases.

        To check if a Discount is possible please Contact our experienced team through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.

    • Available Currencies
      • Most Market Reports on our platform are listed in USD or EURO based on the wishes of our Partners. To avoid currency fluctuations and potential price differentiations we do not offer the possibility to change the currency online.

        Should you wish to pay in a different currency to that advertised online we do accept payments in USD, EURO, GBP and PLN. The price will be calculated based on the relevant exchange rate taken from our National Bank.

        To pay in a different above currency to that advertised online please Contact our team and a quotation will be sent within a couple of hours with payment details.

    • Licenses
      • License options vary from Partner to Partner as is usually based on the number of Users that will benefitting from the report. It is very important that License ordered is not breached as this could have potential negative consequences for you individually or your employer.

        If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.

    • Global Site License
      • The Global Site License is the most comprehensive license available. By selecting this license, the Market Report can be shared with other ‘Allowed Users’ and any other member of staff from the same organisation regardless of geographic location.

        It is important to note that this may exclude Parent Companies or Subsidiaries.

        If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.

    • Formats
      • The most common format is PDF, however in certain circumstances data may be present in Excel format or Online, especially in the case of Database or Directories. In addition, for certain higher license options a CD may also be provided.

        If you have questions or need clarification about the specific formats we recommend you to Contact us and a detailed explanation will be provided.

    • Delivery
      • Delivery is fulfilled by our partners directly. Once an order has been placed we inform the partner by sharing the delivery email details given in the order process.

        Delivery is usually made within 24 hours of an order being placed, however it may take longer should your order be placed prior to the weekend or if otherwise specified on the Market Report details page. Additionally, if details have been not fully completed in the Order process a delay in delivery is possible.

        If a delay in delivery is expected you will be informed about it immediately.

    • Shipping Charges
      • As most Market Reports are delivered in PDF format we almost never have to add additional Shipping Charges. If, however you are ordering a Higher License service or a specific delivery format (e.g. CD version) charges may apply.

        If you are concerned about additional Shipping Charges we recommend you to Contact us to double check.

  • Ordering
    • By Credit Card
      • We work in Partnership with PayU to ensure payments are made securely in a fast and effortless way. PayU is the e-payments division of Naspers.

        Naspers operates in over 133 International Markets and ranks 3rd Globally in terms of the number of e-commerce customers served.

        For more information on PayU please visit: https://www.payu.pl/en/about-us

    • By Money Transfer
      • If you require an invoice prior to payment, this is possible. To ensure a speedy delivery of the Market Report we require all relevant company details and you agree to maximum payment terms of 30 days from receipt of order.

        With our regular clients deliver of the Market Report can be made prior to receiving payment, however in some circumstances we may ask for payment to be received before arranging for the Market Report to be delivered.

  • Security
    • Website security
      • We have specifically partnered with leading International companies to protect your privacy by using different technologies and processes to ensure security.

        Everything submitted to Scotts International is encrypted via SSL (Secure Socket Layer) and all personal information provided to Scotts International is stored on computer systems with limited access in controlled environments.

    • Credit Card Security
      • We partner with PayU (https://www.payu.pl/en/about-us) to ensure all credit card payments are made securely in a fast and effortless way.

        PayU offers 250+ various payment channels and eWallet services across 4 continents allowing buyers to pay electronically, whether on a computer or a mobile device.

PLEASE SELECT LICENSE