By Stephan Hütter
Pharmaceutical companies have been outsourcing processes for decades now. But as market and regulatory dynamics become more complex, managing mature portfolios globally can be deeply fraught.
Organizational models mean biopharmaceutical companies can struggle with resource constraints, especially in local affiliate markets or when balancing the need to support an established portfolio with having your internal talent focus on new launches.
Large companies might have 100 or more operating companies and affiliates globally supporting both well-established products and helping to launch new products. This can place a huge burden on those local affiliates since they must manage the country-specific requirements while adjusting to new technical requirements from a regulatory and corporate perspective.
The demands placed on affiliates can vary depending on the organizational structure. Under an umbrella model, headquarters determines the technology and processes and is responsible for coordinating efforts across regions. A collaborative model encourages a flow of information between headquarters and the affiliates. And a dispersed model makes affiliates responsible for maintaining products locally. In any of these models, there is potential for gaps and challenges to arise because local resources are limited, they lack the expertise to navigate complex and changing requirements, they lack the automation capabilities to optimize processes and they often don’t have the wherewithal to manage risk.
Partnering for better processes
A tailored and blended outsourcing model overcomes these challenges and many more. For example, by working with an outsourcing partner that can integrate regulatory, quality, safety, risk management and labeling activities, companies achieve lower maintenance costs.
Another advantage is the opportunity to develop models around task rather than function, which ensures collaboration between different functions and geographies, allowing companies to respond more rapidly to any changing priorities.
An outsourcing partnership built on knowledge and innovation delivers expertise that generally can’t be found internally, allowing companies to keep pace with the latest digital advancements. For example, by leveraging automation companies can optimize processes.
Outsourcing partners have the advantage of knowing industry standards and best practices gained from working with many different clients, bringing greater efficiencies to all. They also have access to specialist expertise and cutting-edge technology solutions that can bring benefits to many different parts of the business.
Adopting a cautious approach
All these are good reasons why the new wave of outsourcing needs to span in-country, near-shore, and offshore resources to bring in expertise, knowledge and innovation. However, a rapid, unplanned transition to this new outsourcing model is not advised. Rather, companies should adopt a considered approach – one that incorporates key performance indicators. In addition, governance and clear oversight are needed to ensure checks and balances. The roles and responsibilities of all stakeholders, including product teams, senior management and steering committees, must be made clear. And there needs to be a good support system with clear lines of communication.
Outsourcing the mature portfolio through a more strategic, expert-driven approach will be transformative for companies. The key to success lies in good planning, well-defined milestones, continuous communication and collaboration.