Regulatory Affairs Outsourcing; Has Become an Increasingly Common Practice in the Pharma and Biotech Industry

 

Regulatory affairs outsourcing are the services used within regulated industries, such as energy, telecom, banking, agrochemicals, medical devices, pharmaceuticals, etc. to gain fast regulatory approvals from various organizations. Over the past few years, regulatory affairs outsourcing market has grown significantly. With the increasing number of clinical trials, the demand for regulatory outsourcing services is also increasing. Outsourcing services are widely used in the healthcare industry. According to ClinicalTrials.gov, around 347,033 trials were registered in the United States as of July 2020, as compared to around 325,834 by the end of 2019.

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including complementary medicines, cosmetics, agrochemicals, pesticides, medical devices, veterinary medicines, etc. Moreover, regulatory affairs outsourcing services are used by the companies responsible for manufacturing these products to ensure manufactured products are safe to make a valuable contribution to public health and well-being. Small- and mid-size companies hire regulatory consultants to manage their regulatory affairs in the new territories.

Outsourcing is the act of writing, reviewing, editing, and arguing legal documents on behalf of a client in the arena of business regulation. A lot of this task can be done by employees within an organization but it is mostly outsourced since it is time consuming, complex, and sometimes even tricky. The main goal of regulatory affairs outsourcing is to assist businesses. A regulatory submission is one example of a regulatory document that can be written and submitted by a professional to help a business gain approval from the regulatory bodies. However, the process is extensive and can take months to finish depending on the size of the business.

Regulatory affairs outsourcing has become an increasingly important practice in the healthcare industry. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are two major international regulatory agencies that regulate more than half of medical devices worldwide.