Regulatory Reporting and Compliance Market 2021 Analysis, Reviews and Precise Outlook | Genpact Ltd., IQVIA Holdings Inc, Certara, L.P., Pharmaceutical Product Development, LLC (PPD), and Charles River Laboratories International, Inc.

The Regulatory Reporting and Compliance market studied is expected to grow with a CAGR of +9 % over the forecast period.

The regulatory bodies remain strict and stick to their regulatory process but with the outbreak of the COVID-19 pandemic, they enabled flexibility in regulations to make treatment and cure rapidly accessible and developed in these tough times. The regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the United States Food and Drug Administration (USFDA), and European Medicines Agency (EMA) took proactive steps to support the industry. To accelerate the approval procedure; regularly updated guidelines on flexibility are issued to meet compliance, the routine inspection was postponed and reporting was shifted to electronic mode.

The “Regulatory Reporting and Compliance Market” report is an in-depth study of the market, along with an analysis of its key segments. The relationship is built through extensive primary and secondary research. In-depth market data is generated through interviews and data collection from industry experts and professionals. The study is a detailed document on key aspects of the markets including trends, segmentation, growth prospects, opportunities, challenges, and competitive analysis.

The report is updated with the impact of the currently ongoing COVID-19 pandemic. The pandemic has dynamically affected key market segments and changed the growth pattern and demands in the Regulatory Reporting and Compliance market. The report covers an in-depth analysis of these changes and provides an accurate estimate of the market growth forecast after the impact of the pandemic.

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Some of the key players operating in the Regulatory Reporting and Compliance market are Genpact Ltd., IQVIA Holdings Inc, Certara, L.P., Pharmaceutical Product Development, LLC (PPD), and Charles River Laboratories International, Inc.

Recent Developments

In July 2021, the United States of Food and Drug Administration (USFDA) issued final guidelines for providing regulatory submission in alternate electronic format for the industry. The recommendations apply to contents of New Drug Application (NDAs), Abbreviated New Drug Application (ANDAs), Drug Master File (DMFs), Investigational New Drug Application (INDs), Biologics License Application (BLA) to be submitted to Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).

In July 2021, ICON plc announced the completion of the acquisition of PRA Health Sciences with transactions valued in cash and stock of $12 billion. The union of organizations will enable customers to reduce their developmental costs and time.

The digitalization and involvement of automated technological solutions would provide a significant reduction in time, cost, and efforts to achieve business goals. The unlock to intelligent automation technology will enable publishing, submissions, labeling, approval notifications to configure to faster design improvement and governance of workflow in a transparent and trackable manner. Thus, concerning the above-mentioned facts, the regulatory reporting and compliance market is expected to witness huge growth over the forecast period.

Regulatory reporting and compliance are the mandatory procedure for the healthcare industry, the lack of technologically advanced infrastructure in developing countries and complicated local and global regulatory norms may obstruct the growth of the market.

Scope of the Report

Regulatory compliance means being adherence to the legal, ethical, and professional standards led down by regulatory agencies of that region and violation of which may lead to punishments and fines. Meeting these regulatory requirements is extremely essential for players of the regulated industry like pharmaceuticals, medical devices, and other healthcare sectors. The regulations are drawn by regulatory agencies like the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Health Canada (HC), etc. to make sure the quality and safety of available products by organizations in the healthcare industry. Regulatory reporting is the submission of raw or summary data needed by regulators to evaluate an organizations’ operations, thereby determining the status of compliance with the applicable regulatory provision. 

This report segments the global Regulatory Reporting and Compliance market on the basis of Types are:

Regulatory Consulting
Product Registration and Clinical Trial Application
Legal Representation
Regulatory Writing and Publishing
Other Regulatory Services

On the basis of Application, the Global Regulatory Reporting and Compliance market is segmented into:

Pharmaceutical Companies
Medical Device Companies
Biotechnology Companies

The report is mainly segmented into several key regions, with sales, revenue, market share, and growth rate in these regions, covering:

North America (United States, Canada and Mexico)
Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
South America (Brazil, Argentina, Colombia, and Rest of South America)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)

Key Market Trends

Outsourcing Regulatory Reporting and Compliance Services Segment is Expected to Hold Significant Market Share Over the Forecast Period

Regulatory reporting and compliance outsourcing means contracting with a third party in form of an agreement or deal for handling those particular segments for the business. The regulatory functions are challenging in a highly regulated industry and hiring a third party to foresee these functions has become increasingly important to thrive in a competitive and innovative industry such as healthcare. The need to maintain compliance, obtain approval for new products, early release in the market, reporting publishing, and submissions requires large budgets. The outsourcing regulatory reporting and compliance market have been fueled up by the availability of technologically aided solution like automated software, big data management software, etc. Further, in January 2021, Genpact Ltd announced that it has acquired ‘Enquero’, a data engineering and data-led digital transformation service organization. The acquisition will increase Genpact’s ability to leverage data and cloud technologies to drive digital transformation services through advanced analytics. Moreover, organizations like Celegence, Freyr Solutions offers wide range regulatory services from publishing, labeling, compliance consulting, regulatory operation management and, so on to the life science organization with their software aided solutions to large organization. Since the integration of Information Technology for making regulatory reporting and compliance boosts the outsourcing segment the demand is expected to increase over the forecast period.

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Important Questions Answered

What is the growth potential of the Regulatory Reporting and Compliance market?

Which company is currently leading the Regulatory Reporting and Compliance market? Will the company continue to lead during the forecast period 2021-2028?

What are the top strategies that players are expected to adopt in the coming years?

Which regional market is anticipated to secure the highest market share?

How will the competitive landscape change in the future?

What do players need to do to adapt to future competitive changes?

What will be the total production and consumption in the Regulatory Reporting and Compliance market by 2028?

Which are the key upcoming technologies? How will they impact the Regulatory Reporting and Compliance market?

Which product segment is expected to show the highest CAGR?

Which application is forecast to gain the biggest market share?

The research includes historic data from 2015 to 2021 and forecasts until 2028 which makes the report's an invaluable resource for industry executives, Marketing, Sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs.

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