DDReg Pharma

DDReg Pharma
Regulatory Compliance

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.
Be it multinational or mid-size pharmaceutical organizations, global expansion activities for obtaining faster approvals in various markets are being conducted and are significantly contributing to outsourcing models being adopted for regulatory and pharmacovigilance services. In 2021, the outsourcing market size for global regulatory affairs was around $6.5 billion, and is expected to grow at a CAGR of 8.9% by 2030 [1]. A combination of more research & development activities, clinical trial applications, and product registrations have resulted in the growth of regulatory affairs outsourcing.
The pressure to obtain timely approval from regulatory authorities across the globe, in various markets, is increasing and encouraging pharmaceutical organizations to outsource regulatory affairs services to obtain market approval while also maintain regulatory compliance. Larger organizations look to create long-lasting and strong relationships with service providers to ensure smooth operational working, thus require service providers that can meet their needs. Medium sized organizations lack the in-house regulatory capability and sufficient capital to develop their own, hence look to establish partnership with regulatory affairs service providers.
In 2019, the market for outsourcing pharmacovigilance services was just under $4 billion and is expected to grow at a CAGR of 15.8% by 2026 [2]. Outsourcing crucial pharmacovigilance activities such as Adverse Drug Reaction (ADR) monitoring, case processing activities, risk management & mitigation strategies enable organizations to focus on specific drug safety aspects while minimizing cost. In-house pharmacovigilance departments, that are compliant to international standards, can be costly to set up and maintain. India and China are among the few countries in the Asia Pacific pharmaceutical industry that is favourable for outsourcing pharmacovigilance services. This is due to the availability of high skillsets at lower costs, and a comparatively larger group of pharmacovigilance professionals.
Outsourcing regulatory affairs and pharmacovigilance services is increasingly becoming common and driving the market growth. Organizations seek to establish expert and comprehensive support for obtaining product approval and the smooth functioning of operational tasks. This industry is constantly growing with a lot of activity, particularly when it comes to international cooperations and mergers & acquisitions while keeping track of the changes and emerging innovations. Organizations ultimately want to increase operational efficiency and minimize cost and look to outsource services for these reasons. Therefore, identifying service providers that are experts in their business and transparent at every stage is crucial.
-Akshita Srivastava, Senior Medical Writer at DDReg Pharma

[1] Report: Grand View Research, 2021. Regulatory Affairs Outsourcing Market Size, Share & Trends Analyziz Report by Category (Biologics, Medical Devices), By Company Size (Medium, Large), By Indication, By Stage, By Services, By End Use, And Segment Forecasts, 2022-2030 [Internet]. Cited 2022 June 13, available here.

[2] Report: Global Market Insights, 2020. Pharmacovigilance Outsourcing Market Size by Service (Pre-marketing Pharmacovigilance Services, Post marketing Pharmacovigilance Services), By Service Providers, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2020 – 2026 [Internet]. Cited 2022 June 13, available here.