As part of the Regulatory Organization Assessment, an initial step towards regulatory outsourcing is to asses the current product portfolio.
The assessment of resources utilization across regulatory organization can also be done based on products. It is likely with many organizations that the marketed matured products portfolio includes top performing products in various markets along with several low performing products in those countries/regions. Identifying high and low performing products/markets helps prioritize time utilization of internal resources. In case of low performing products, that are commercially low risk portfolio for the company, an organization can plan to identify a partner to manage that portfolio to reduce overall operational costs for the organization.
A simpler structure could be following 80/20 or similar ratio strategy as per sponsor’s current state where sponsor’s internal regulatory teams can manage the 80% high performing products, whereas an external partner can take ownership of managing remaining 20% of portfolio in a KPI driven outsourcing framework with compliance oversight from the sponsor. The percentage of portfolio managed internally versus outsourced is subject to decision from the sponsor.
A product based outsourcing structure is often referred as Product Stewardship where the partner owns end to end responsibility of the product lifecycle maintenance globally using a combination of centralized and localized teams. Higher up in the governance structure, the executive or project committee includes responsible members from the sponsor.
This method is mostly applied on matured/marketed products by sponsors. In general, companies prefer to keep the developmental and critical products regulatory affairs in-house due to information safety, intellectual property, deeper in-house scientific specialization and other factors.