Global Regulatory Service Providers Landscape


This report includes assessment of 51 companies providing regulatory services worldwide. The service providers are classified under different categories based on company’s primary nature of services. For example, the market landscape includes companies including Clinical Research Organizations and Large Scale Technology Consulting companies, etc. who also provide Regulatory Services.

Types of Companies

Based on the Main Category of Services companies provide, about 37% companies are focused regulatory services providers where as 27% companies are CROs offering regulatory services as part of their overall value proposition. Majority of leading technology and consulting companies have a strong regulatory services proposition including regulatory affairs, regulatory operations outsourcing services.


The regulatory services provider landscape is distributed with certain companies specialized in providing services in one or more countries, whereas companies whose scope of services expand beyond two or more countries. Large organizations and CROs have presence in multiple countries to support with regional regulatory requirements and operational needs. The following graph represents companies segmented based on number of countries their offices are located in.

Further, these companies are assessed based on number of countries they provide services in The information is segmented based on companies that provide services in global locations (often more than 50 countries), those providing services in more than 10 countries and less than 10 countries respectively.. For example, a company may not have its own presence in one of the countries in Middle East, however, it can provide specific services that do not need a local presence.

Employees Headcount/ Team size

An assessment of current employees working with these companies was conducted on LinkedIn to assess their global team size. The following chart is grouped based on companies’ employee strength worldwide. This figure only represents the information available on LinkedIn on the day of assessment, the actual employee strength will vary.


Since the service providers deal with sensitive data and operate in a highly quality driven environment, it is often required by their clients to obtain quality and information safety related and/or their audits done. Obtaining relevant certifications also provides a competitive edge to the service providers. The following graph represents number of services providers who have different certifications.


Several regulatory affairs and operations service providers have built in-house technologies addressing tool requirements for various regulatory functions. The technologies range from end to end workflow management to accelerators for improving processes and drive efficiencies. Some of the companies providing such software are mentioned below. A complete list of software available in the market are summarized in the article


· NEXT HCP Journey Optimization

· NEXT Forecasting

· NEXT Clinical Trial Design

· NEXT Regulatory Submissions Planning

· NEXT Adverse Event Management

· NEXT Commercial Content Intelligence

· Next Patient Engagement

ICON plc



· Safety Reporting Solution

· One Search

· Evidence Platform


· Medical Imaging Technology



· PDx - POP

· PubsHub


· Patient Engagement Platform

Freyr Solutions

· Publishing- SUBMIT

· Document Management- rDMS

· Ingredient Regulatory Compliance - iREADY

· Labelling- LABEL360



· Product Registration - SPAR




· QMS - Sparta

· Document Submission - eCTD & eDMS

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