Outsourcing is increasingly common within the pharmaceutical and medical device industries, especially within the Regulatory Affairs, Pharmacovigilance and Medical Information functions. Regulatory Affairs outsourcing in particular is very common, with many companies seeking expert support and partnership for new products and the effective management of operational tasks.

In an evolving marketing environment driven by; mergers, acquisitions, globalisation, and optimisation blended with the race for new innovation amidst changing regulations, increasing demands are being placed on research and development. Consequently, companies are increasingly seeking and relying on partnerships with contract organisations. The concept of outsourcing is now a common and successful practice. It therefore comes as no surprise that in 2019, a market analysis report by Grand View Research, reported that the global regulatory outsourcing market was valued at a staggering US$6.3 billion.  It is further expected to grow annually at a rate of 11.9% from 2020 to 2027.

Why are companies continually choosing to outsource Regulatory Affairs?

The simple answer comes down to operational efficiency and cost. In a world of increasing competition and innovation, companies are turning to outsourcing partners for expert support. Based on their specialised skill and knowledge, to register new innovations, as well as management of operational tasks, such as product lifecycle maintenance. In doing so outsourcing enables greater flexibility for companies to manage peaks in workload while keeping the focus on their core competencies and long-term goals. Increase their productivity and operational efficiency. In turn this allows for faster regulatory approvals, entry into the market and gaining higher market share as a result. Consequently this could result in a larger returns on investment.

What gets outsourced?

Companies large and small engage with outsourcing partners in different ways, for a variety of tasks ranging from simple to complex projects. The type of work which gets outsourced therefore can be broadly categorised into 2 main forms of outsourcing in Regulatory Affairs:

Technical outsourcing which involves:

• Pharmaceutical-chemistry and clinical regulatory writing
• Literature searches for submissions
• Preparation and compilation of regulatory applications
• Compliance activities such as SOP writing, audit readiness and regulatory training

Strategic outsourcing which involves:

• Liaising and negotiating with regulatory authorities
• Regulatory strategy development
• Global submission coordination and management
• Ongoing regulatory maintenance of product licenses
• Regulatory intelligence

Both technical and strategic outsourcing offer companies different advantages and motives to pursue. For example, technical outsourcing is often carried out on a project-by-project basis and is generally a short-term arrangement. It allows companies to manage workload allowing them to address short-term capacity constraints. Strategic outsourcing on the other hand allows for flexible internal resourcing. Thus providing opportunities for companies to identify and focus on their core strengths and long term goals with a lean cost base. It is a competence-based model which enables companies to readily select the most suitable outsourcing partner with the quality of skill-sets they require that they may not have internally.

Choosing who to outsource to and how?

If not done right outsourcing Regulatory Affairs can come with its own challenges, such as:

• Determining what and how to outsource
• Increase in project management
• Perception of loss of critical skills within the business
• Lack of information flow between company and outsourcing partner e.g. internal procedures, roles and responsibilities, key deliverables
• Not cost-effective

The success of outsourcing, and the realisation of the opportunities it holds, therefore lies in who companies choose to outsource to and how. In choosing an appropriate outsourcing partner, companies should seek reliable partners with technical and strategic capability and relevant expertise coupled with robust internal procedures to effectively manage projects.  

Developing an outsourcing model and process between a company and their outsourcing partner is crucial to success. Such a model should define:

• Tasks to be outsourced
• Deliverables and associated timelines and costs
• Project and company objectives
• Roles and responsibilities
• Flow of information
• Details of required training to ensure compliance with company procedures

Key takeaways

Outsourcing Regulatory Affairs, whether technical or strategic, is a growing trend in our industry. Allowing companies to focus on their strategic imperatives.  We will see outsourcing continue to evolve and expand. While there are a numerous opportunities for both companies and outsourcing partners to succeed, there are challenges associated. A well-defined outsourcing model is imperative to help overcome the challenges and realise the full potential of the advantages outsourcing can bring.