Outsourcing regulatory compliance solutions

In an era of technological advancement, and easy access to such disruptors, pharmaceutical organizations are increasingly looking to outsource their solutions to enhance efficiency and reduce cost. Inevitably, there are many benefits to outsourcing in the pharmaceutical industry that include operational control, faster time-to-market, increased flexibility & revenue, quality production and ultimately lead to increased efficiency. Skills and services can be upscaled or downscaled as necessary while leveraging technology. However, when regulations and compliance are involved, pharmaceutical organizations can be apprehensive as the reputation of the organization, added stress, and high costs are at stake. Thus, outsourcing automatically seems more complex and riskier, however, the benefits still outweigh the risks

It is important for pharmaceutical organizations to identify outsourcing businesses that know their line of work thoroughly and conduct risk assessments regarding the services they have to offer. On this basis, they can understand which processes they should or should not outsource. Transparency between the service provider and the organization is crucial, therefore, efforts to build a trustworthy and amicable rapport is necessary.

Multinational and mid-size pharmaceutical organizations are conducting global expansion activities to obtain faster approvals in various markets, and they are significantly contributing to the adoption of outsourcing models for regulatory and pharmacovigilance services. The global regulatory affairs outsourcing market is expected to be worth approximately $6.5 billion in 2021 and to grow at an 8.9% CAGR by 2030. Regulatory affairs outsourcing has increased as a result of increased R&D activities, clinical trial applications, and product registrations.

The pressure to obtain timely approval from regulatory authorities in various markets around the world is increasing, encouraging pharmaceutical companies to outsource regulatory affairs services in order to obtain market approval while also maintaining regulatory compliance. Larger organizations seek long-term and strong relationships with service providers to ensure smooth operational functioning, and thus require service providers who can meet their requirements. Because medium-sized businesses lack in-house regulatory capability and sufficient capital to develop their own, they seek to form partnerships with regulatory affairs service providers.

The market for outsourcing pharmacovigilance services was just under $4 billion in 2019 and is expected to grow at a 15.8% CAGR by 2026. Outsourcing critical pharmacovigilance activities such as ADR monitoring, case processing, risk management, and mitigation strategies allows organizations to focus on specific drug safety aspects while minimizing costs. Setting up and maintaining in-house pharmacovigilance departments that adhere to international standards can be costly.

Outsourcing regulatory affairs and pharmacovigilance services is becoming more common, fueling market growth. The following are the results of a survey conducted by the American Society for the Prevention of Cruelty to animals. This industry is constantly evolving, with a high level of activity, particularly in terms of international collaborations and mergers and acquisitions, as well as keeping track of changes and emerging innovations. Organizations ultimately seek to increase operational efficiency and reduce costs, and for these reasons, they seek to outsource services. As a result, identifying service providers who are experts in their field and transparent at all stages is critical.