FSO vs. FSP: Choosing the right outsourcing model in the age of AI-driven digital enablement

As an Integrated Product Development and Market Access Platform, G&L Scientific leverages decades of industry-leading regulatory and quality expertise to support clients with best-in-class solutions across the entire product pipeline, including a choice of outsourcing models empowered by digital transformation.

In today’s highly regulated and competitive regulatory and quality landscape, companies must strike a balance between efficiency, cost control, and compliance. The integration of AI, automation, and data analytics has transformed outsourcing from a traditional cost-saving measure into a strategic enabler of agility, innovation, and market leadership.

As a result, outsourcing has increasingly become a strategic necessity - it is a critical component of digital acceleration, allowing organizations to optimize internal resources while harnessing cutting-edge technology to enhance compliance, speed, and decision-making.

Understanding and choosing the right model, enhanced by AI-driven insights and digital capabilities, can make all the difference.

Full Service Outsourcing (FSO): A comprehensive AI-enabled approach

FSO is a strategic solution in which a company fully outsources an entire function, such as regulatory affairs or quality assurance, to G&L. By integrating AI, machine learning, and automation into our FSO model, we offer:

• End-to-end accountability - We take full responsibility for regulatory or quality activity, enhanced by predictive analytics, to anticipate risks and ensure proactive compliance throughout the product lifecycle.
• Cost efficiency - AI-powered automation reduces the need for manual processes, cutting overhead costs associated with salaries, training, and infrastructure while leveraging global expertise for maximum savings.
• Operational efficiency with smart workflows - We apply proprietary continuous improvement methodology coupled with AI-driven workflow optimization and robotic process automation (RPA) to streamline processes, reduce errors, and improve speed to market. Clients benefit from streamlined workflows and economies of scale.
• Scalability & flexibility in a digital landscape - Our AI-enhanced FSO solutions dynamically adjust resources in real time to meet changing market demands, ensuring seamless scalability.
• Specialized expertise targeted where it is needed - With experience across multiple regulatory frameworks (FDA, EMA, MHRA, etc.), G&L, as an FSO provider, ensures compliance across all target markets, enabling faster approvals and market entry.
• Reduced management effort through AI-powered data analytics and reporting oversight - Our intelligent monitoring and reporting tools provide real-time insights, minimizing manual oversight and freeing up internal teams to focus on strategic business growth

FSO is ideal for companies looking to fully outsource their regulatory or quality functions, while gaining the benefits of AI-driven automation, predictive analytics, reducing complexity and management burden, through expert-driven, scalable solutions.

Functional Service Provider (FSP): A targeted, technology-enabled solution

FSP is an alternative outsourcing model that allows companies to outsource specific functions or tasks rather than an entire function. Our AI-powered FSP model provides:

• Scalability & flexibility - Organizations can adjust resources as needed, with AI-powered forecasting and workforce optimization, ensuring efficiency within dynamic market conditions.
• Cost efficiency - Outsourcing targeted functions with G&L’s AI-driven smart resourcing optimizes budgets and reduces overhead while maintaining specialized support.
• Operational efficiency - G&L’s advanced analytics and AI-powered automation FSP streamline operations, enabling internal teams to focus on strategic initiatives.
• Specialized expertise enhanced by AI - Our digital platforms allow for an FSP model that provides our regulatory professionals with real-time access to evolving global compliance requirements, freeing their time to add value to client product management.

FSP is best suited for companies that want to maintain control over core functions while leveraging AI, automation, and digital expertise for specific outsourced functions.

Choosing the right model in a digitally transformed world

Both models offer significant benefits but, in the digital age, outsourcing is no longer just about cost savings - it’s about driving transformation. Partnering with a technology-enabled provider like G&L ensures not only cost-effective and operational efficiency, but also the ability to harness AI, automation, and data analytics for scalability, and compliance.

Understanding your organization’s goals and operational needs will help determine the right outsourcing approach for sustainable success.

If your company requires a fully managed regulatory or quality function with minimal internal oversight, FSO is the best choice. However, if you prefer to retain control over core functions while outsourcing specific tasks, FSP provides a more tailored solution.

Our Advisory Practice, built around deep domain expertise, supports clients in their decision-making process,s offering insight and real-world experience in delivering a variety of models to suit specific client situations.

Find out more about our outsourcing options here.