Regulatory outsourcing: key considerations for success

Changes within the ever-evolving global regulatory landscape, such as the transition of trials to comply with EU-CTR or upcoming mandatory IDMP submissions, require an ongoing focus on cross-functional process optimization. Additionally, with emerging initiatives such as robotics and process automation (RPA) delivering technological efficiencies, there are opportunities to drive improvements and effectiveness within processes and deliverables.  

We are seeing an increase in regulatory activities being outsourced, which can be attributed to several factors, including (but not limited to):

• Internal budget pressures
• The increasing number of regulatory submissions
• The need to streamline and automate processes

With tighter budgets, organizations seek ways to optimize their resources by leveraging external expertise in regulatory strategy, dossier preparation, and pharmacovigilance. 

To maximize the potential gains from regulatory outsourcing, it is crucial to understand and capitalize on the key building blocks.  At Parexel, we have identified four main areas of focus: 

1. Core business re-evaluation

To focus staff on the highest value activities, it is essential to identify and prioritize the core functions that drive the most significant impact on future revenue. A re-evaluation of core functions can determine what must be kept in-house versus outsourced. This approach challenges the traditional mindset of focusing staff solely on current revenue-generating regulatory activities. By outsourcing mature portfolio management and the entire process end-to-end, organizations can allocate internal resources more efficiently toward future revenue opportunities.

Parexel case study
This is highlighted by one of our long-term partnerships with a large biopharmaceutical organization. They outsourced end-to-end global regulatory lifecycle management to Parexel for 65 mature products consisting of small molecules, biologics and vaccines. This allowed the organization to reallocate 59 headquarters (HQ) and local full-time equivalents (FTEs) to focus on new development projects, as opposed to working on the mature product portfolio.
 

2. Vendor re-assessment and consolidation

Ensuring business continuity is vital for organizations to maintain uninterrupted operations during disruptions. It is important to review the continuity of service throughout the year to identify vulnerabilities and strengthen processes. Rationalizing in-sourcing towards a more predictable and de-risked model can provide greater control and stability. Shifting from on-premises in-sourcing to remote models offers increased flexibility and scalability. Reducing resources from small, local providers to global, integrated providers enhances efficiency and access to diverse expertise. Reconsidering the location of vendors' resources or right-shoring contractors allows for cost savings, risk mitigation, and improved collaboration. Assessing hybrid or functional outsourcing models provides the opportunity to strike a balance between control and flexibility in the in-sourcing approach. 

Parexel case study
One of our partners, a mid-size biopharmaceutical organization with a mix of mature product portfolio and ongoing new development projects recently assessed their vendor portfolio. It consisted of more than one hundred vendors. Consolidating their providers has enabled them to create an efficient, lean oversight model leading to quicker decision-making and cost savings.

3. Pool resources across delivery models with consolidated vendors

There are three models to consider. All offer flexibility and agility depending on the outsourcing needs:

• In-sourcing: This model provides the advantage of on-demand access to both on-site and off-site resources, allowing for a dynamic and adaptable staffing strategy. The highly flexible nature of in-sourcing enables operations to meet tactical resourcing requests effectively, as they have access to a flexible and evolutive resource pool.
• Hybrid model: This model brings strategic value by offering scalable relief and ensuring business continuity. With a combination of regional FTE based coverage and peak-state support, the hybrid approach provides predictability and flexibility. Organizations can control their resource allocation, efficiently managing resourcing requests while maintaining agility and adaptability in their operations.
• Cross-function outsourcing: This approach allows for effective management of global processes and offers significant benefits, including increased efficiency through performance-based metrics and a focus on continuous process improvement. The ability to scale resources up or down according to the highs and lows of work demands ensures optimal resource utilization. This flexible and adaptive approach allows organizations to align resource allocation with specific business needs, resulting in improved overall operational efficiency.

A recommendation of which model, or combination of approaches will differ depending on a company’s goals and requirements. 

4. Prepare for effective transformation of the regulatory function

To foster innovation, reduce duplication of efforts, and improve overall productivity and compliance, see regulatory function transformation including: 

• Centralizing data entry and consolidating/cleaning data to establish a single source of truth: To provide a solid foundation for continuous data improvement and innovation and to enable automation. By leveraging a core team of specialized users, companies can enhance data accuracy and compliance while reducing the burden on larger user populations.
• Converging towards single, global, and uniform processes and platforms: To facilitate the deployment of global dossiers to reduce content generation efforts. By streamlining processes and adopting a standardized approach, pharmaceutical companies can enhance efficiency and ensure regulatory compliance across multiple markets.
• Piloting RPA and AI: Pilot initiatives aim to explore and validate the automation potential within regulatory functions. By leveraging RPA and AI, companies can optimize routine and repetitive tasks, freeing up valuable resources for more strategic activities while enhancing operational efficiency.

Agile outsourcing with Parexel

Agility is a key aspect of Parexel's regulatory outsourcing strategy. We recognize that each customer's needs and project requirements are different, and therefore, a one-size-fits-all approach may not yield optimal results. Our methodology ensures that the right resources are deployed timely while aligning with our customers’ objectives. Through effective project management and communication, we ensure transparent and collaborative relationships, facilitating efficient knowledge transfer and seamless integration within their teams. This iterative and adaptable approach allows for real-time feedback and modifications to ways of working, thereby fostering continuous improvement and maximizing client satisfaction.
We have a global presence, with strategically positioned offices and experts across major regulatory hubs worldwide. This extensive network allows quick and seamless access to regulatory experts who possess deep knowledge of local regulations and requirements. Parexel's resources are not only geographically diverse but also highly experienced in regulatory affairs. 

Reach out to our experts to make your regulatory journey easier 

Regulatory outsourcing continues to be a crucial driver of success for organizations operating in the life sciences industry. By keeping current with market trends, harnessing the power of technology and AI, and leveraging differentiators such as global resources, expertise, speed, and agility, we deliver comprehensive and tailored regulatory outsourcing services. As the industry landscape evolves, Parexel remains at the forefront, shaping the future of regulatory outsourcing and enabling our customers to navigate the complex and ever-changing regulatory environment effectively. 

To discuss your regulatory outsourcing requirements, please get in touch. We’re always available for a conversation. 

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