Regulatory Affairs Outsourcing Allows Businesses To Free Up Resources And Refocus Their Resources On Strategic Activities

Regulatory Affairs Outsourcing

Regulatory Affairs Outsourcing (RAO) is an increasingly used practice by companies in the pharmaceutical, biotechnological, and medical device sectors. It is a cost-effective way to meet regulatory requirements and obtain approvals for new products.

Increasing costs and the need for resources are the main drivers behind the Regulatory Affairs Outsourcing trend. Moreover, the demand for outsourcing is increasing in emerging economies. The rapid development of the life sciences sector is another driving factor.

The Global Regulatory Affairs Outsourcing Market Size Was Valued At US$ 3,683.7 Million In 2019, And Is Expected To Exhibit A CAGR Of 12.0% Over The Forecast Period (2019 – 2027).

Several pharmaceutical and medical device companies are investing in R&D activities. However, they are not able to build an in-house regulatory affairs team due to lack of capital. Hence, they prefer to outsource the services to a service provider with the necessary experience.

Furthermore, Regulatory Affairs Outsourcing firms have the ability to expedite the regulatory process. They can also help ensure regulatory compliance. They can write protocols for clinical trials and provide digital IND safety reporting services. This allows them to supplement their current regulatory staff.

Regulatory Affairs Outsourcing is a process where an organization pays a service provider to perform specific tasks. Some of the activities that can be outsourced are: eCTD submissions, digital IND safety reporting, drug labeling and clinical trial applications.

Regulatory Affairs Outsourcing helps refocus the regulatory team's attention to core competencies, such as regulatory compliance, product approval, and data management. By outsourcing these non-core activities, businesses can increase their focus on marketing, sales, and other core functions. This can also result in more efficient reimbursements and reduced costs. Depending on the scope of the project, companies can choose among various outsourcing models.

Regulatory affairs outsourcing companies can also supplement a company's current regulatory team. These firms can write protocols for clinical trials and assist in getting a new product approved. However, establishing an in-house regulatory affairs department in an offshore facility is not feasible. To overcome this challenge, businesses must outsource the activities.

Regulatory Affairs Outsourcing firms are able to reduce excessive workloads. Often, these workloads are caused by overly ambitious goals. Alternatively, they may be triggered by external factors.

Eli Lilly acquired Dermira’s immunology portfolio in 2020. This is estimated to have a positive impact on the development of COVID-19 vaccines. 

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